Customizable methods and systems of growing and harvesting cells in a hollow fiber bioreactor system

ABSTRACT

Embodiments described herein generally relate to methods and systems for customizing protocols for use with a cell expansion system. Through a user interface, a user may create a custom task for loading, growing and/or harvesting cells. A custom task may comprise one or more steps, in which a user may add or omit steps, as desired. Data may be entered for settings associated with a custom task, in which embodiments provide for such data to be entered each time the custom task is performed. In another embodiment, the settings for a custom task may be configured, in which such settings may be stored and retrieved upon selection of the custom task. Customization and configuration of a custom task may occur using a diagram view of the cell expansion system, in which process settings are associated with graphical user interface elements.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of, and claims priorityto, U.S. patent application Ser. No. 15/610,224, entitled, “CustomizableMethods and Systems of Growing and Harvesting Cells in a Hollow FiberBioreactor System,” filed on May 31, 2017, and issued as U.S. Pat. No.10,669,519 on Jun. 2, 2020, which is a divisional application of, andclaims priority to, U.S. patent application Ser. No. 13/269,351,entitled, “Customizable Methods and Systems of Growing and HarvestingCells in a Hollow Fiber Bioreactor System,” filed on Oct. 7, 2011, andissued as U.S. Pat. No. 9,677,042 on Jun. 13, 2017, which claims thebenefit of U.S. Provisional Application Ser. No. 61/391,152, filed onOct. 8, 2010, and entitled, “Methods of Growing and Harvesting Cells ina Hollow Fiber Bioreactor System” and of U.S. Provisional ApplicationSer. No. 61/434,726, filed on Jan. 20, 2011, and entitled, “Methods ofGrowing and Harvesting Cells in a Hollow Fiber Bioreactor System.” Thedisclosures of the above-identified applications are hereby incorporatedby reference in their entireties as if set forth herein in full for allthat they teach and for all purposes.

FIELD

Embodiments of the present disclosure relate to cell growth in cellexpansion systems.

BACKGROUND

The use of stem cells in a variety of medical treatments and therapiesis receiving growing attention. Cell expansion systems can be used togrow stem cells, as well as other types of cells, such as bone marrowcells which may include stem cells. Stem cells which are expanded fromdonor cells can be used to repair or replace damaged or defectivetissues and are considered for treating a wide range of diseases. Cellexpansion systems (CESs) are used to expand cells and may be used toexpand donor stem cells from bone marrow. Stem cells may be grown inhollow fiber bioreactors in a cell expansion system.

SUMMARY

Embodiments of the present disclosure generally relate to providingprocessor-implemented methods and systems for customizing protocols ortasks for use with a cell expansion system. Aspects of particularembodiments provide for a user interface (UI) and the use of graphicaluser interface (GUI) elements for creating a custom or user-definedprotocol or task. In embodiments, steps may be added and/or omitted froma custom or user-defined task. Further embodiments provide for a customor user-defined task to be configured. In embodiments, UI or GUIelements associated with settings for particular steps of a customprotocol or task used with the cell expansion system are rendered anddisplayed in diagram windows on a display device. Such UI or GUIelements may be selected to configure one or more settings. Inembodiments, configured settings for a custom or user-defined task arestored and available for subsequent retrieval in performing actionsrelated to the task.

The disclosure relates to a processor-implemented method for customizinga task for use with a cell expansion system. The method includes thesteps of providing a cell expansion system; providing a bioreactor inthe cell expansion system; providing a user interface for customizing afirst custom task; receiving, through the user interface, a firstselection of the first custom task, wherein the first custom taskcomprises a first step; providing a first setting for the first step ina table view; receiving a second selection to add a second step to thefirst custom task; providing a second setting for the second step in thetable view; receiving a third selection to configure the first step ofthe first custom task; determining the first setting is configurable;and providing a diagram view of the cell expansion system, comprising:associating the diagram view with the first step, providing the firstsetting as a first graphical user interface element, and, in response todetermining the first setting is configurable, enabling the firstgraphical user interface element for selection.

In at least one embodiment, the receiving a second selection to add asecond step includes receiving a type of step to add, in which the typeof step comprises one or more from the group consisting of: wash outlines, wash out lines through membrane, wash rapidly, harvest cells, addbolus, and custom. In at least one embodiment, receiving a firstselection of a first custom task comprises: receiving a touch event on adisplay area of the user interface of the cell expansion system,determining a location of the touch event, mapping the location of thetouch event to the first graphical user interface element, anddetermining the first graphical user interface element is associatedwith the first setting. In at least one embodiment, the touch event isreceived on a touch screen. In at least one embodiment, displaying thediagram view of the cell expansion system further comprises: depictingan intracapillary side of the bioreactor, and depicting anextracapillary side of the bioreactor.

In at least one embodiment, the method further includes determiningwhether the first setting is associated with a numeric value; and, ifthe first setting is associated with the numeric value, providing a dataentry pad in the diagram view to receive the numeric value. In at leastone embodiment, the method further includes if the first setting is notassociated with the numeric value, determining if the first setting isassociated with a menu of selection options; and, if the first settingis associated with the menu of selection options, providing the menu ofselection options in the diagram view. In at least one embodiment, themethod further comprises: receiving data for configuring the firstsetting, storing the data received for configuring the first setting,receiving an indication to execute the first custom task, and executingthe first custom task with the data received for configuring the firstsetting.

In at least one embodiment, the first setting comprises one or more fromthe group consisting of: intracapillary inlet, intracapillary inletrate, intracapillary circulation rate, extracapillary inlet,extracapillary inlet rate, extracapillary circulation rate, rocker, andstop condition. In at least one embodiment, the enabling of the firstgraphical user interface element for selection comprises: associating afirst visual indicia with the first graphical user interface element,and, in response to determining the first setting is configurable,associating a second visual indicia with the first graphical userinterface element.

The disclosure also relates to a cell expansion system. The cellexpansion system comprises: a cell expansion system, including abioreactor; a processor coupled to the cell expansion system; a displaydevice, in communication with the processor, operable to display data;and a memory, in communication with and readable by the processor, andcontaining a series of instructions that, when executed by theprocessor, cause the processor to: receive a first selection of a task;provide a task type, wherein the task type comprises one or more fromthe group consisting of: a predetermined task type and a user-definedtype; receive a second selection of a first user-defined task, whereinthe first user-defined task comprises a first process; provide one ormore settings for the first process in a table view; provide first dataassociated with at least a first setting of the one or more settings forthe first process; receive an indication to add a second process to thefirst user-defined task; add the second process to the firstuser-defined task; receive an indication to modify the first process;display a diagram view associated with the first process, wherein thedisplaying comprises: associate the diagram view with the first process,provide the first setting as a first graphical user interface element,and, in response to determining the first setting may be modified,enabling the first graphical user interface element for selection;receive second data associated with the first setting; receive anindication to execute the first user-defined task; and execute the firstuser-defined task, comprising: execute the first user-defined task usingthe received second data associated with the first setting.

In at least one embodiment, the system further comprises after executingthe first user-defined task, receive a second indication to execute thefirst user-defined task; and execute the first user-defined task usingthe first data associated with the at least a first setting. In at leastone embodiment, the system comprises: in response to receiving theindication to add the second process, retrieve a type of process to add;provide a selection window of the type of process to add; and receive athird selection of the type of process to add. In at least oneembodiment, the type of process to add comprises one or more from thegroup consisting of: wash out lines, wash out lines through membrane,wash rapidly, harvest cells, add bolus, and custom. In at least oneembodiment, the system comprises: receive a fourth selection toconfigure the first user-defined task; display a diagram view comprisingthe first and second processes; receive a fifth selection to configurethe second process; configure the second process; and store theconfiguration of the first user-defined task. In at least oneembodiment, the system comprises after adding the second process to thefirst user-defined task, receive an indication to omit the secondprocess from the first user-defined task; and omit the second processfrom the first user-defined task. In at least one embodiment, thedisplaying the diagram view comprises depicting an intracapillary sideof the bioreactor of the cell expansion system; and depicting anextracapillary side of the bioreactor.

The disclosure further provides for a non-transitory processor-readablestorage medium storing executable instructions which when executed by aprocessor perform a method of customizing a task used with a cellexpansion system. The method includes the steps of receiving anindication to create a first custom task for use with the cell expansionsystem, wherein the cell expansion system comprises a bioreactor;receiving a first selection of the first custom task, wherein the firstcustom task comprises a first process; providing a setting associatedwith the first process; receiving a second selection to add a secondprocess to the first custom task; in response to receiving the secondselection, retrieving a type of process to add; providing a selectionwindow comprising the types of processes to add, wherein the types ofprocesses to add comprise one or more from the group consisting of: washout lines, wash out lines through membrane, wash rapidly, harvest cells,add bolus, and custom; receiving a third selection of the type ofprocess to add; adding the selected type of process as the secondprocess to the first custom task; receiving data associated with a firstsetting of the first process; and executing the first custom task withthe data received for the first setting of the first process.

In at least one embodiment, the method includes receiving an indicationto configure the first custom task; receiving a numeric value forconfiguring a second setting of the first process; and storing thenumeric value in association with the first custom task. In at least oneembodiment, the method includes: based on the numeric value received forthe second setting, determining to calculate a second numeric value fora third setting of the first process; automatically calculating thesecond numeric value; providing the second numeric value for the thirdsetting of the first process; and storing the second numeric value inassociation with the first custom task.

This Summary is included to provide a selection of concepts in asimplified form, in which such concepts are further described below inthe Detailed Description. This Summary is not intended to be used in anyway to limit the claimed subject matter's scope. Features, includingequivalents and variations thereof, may be included in addition to thoseprovided herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure may be described by referencingthe accompanying figures. In the figures, like numerals refer to likeitems.

FIG. 1 illustrates a perspective view of a hollow fiber bioreactor inaccordance with embodiments of the present disclosure.

FIG. 2 depicts a schematic of one embodiment of a cell expansion system.

FIG. 3 illustrates a perspective view of the cell expansion system witha pre-mounted fluid conveyance device in accordance with embodiments ofthe present disclosure.

FIG. 4 depicts a perspective view of the housing of the cell expansionsystem in accordance with embodiments of the present disclosure.

FIG. 5 illustrates a perspective view of the pre-mounted fluidconveyance device in accordance with embodiments of the presentdisclosure.

FIG. 6 depicts a perspective view of the air removal chamber inaccordance with embodiments of the present disclosure.

FIG. 7 illustrates an example logical representation of an environmentfor interacting with a UI of a cell expansion system in accordance withembodiments of the present disclosure.

FIG. 8 depicts an example UI showing GUI elements and features forconfiguring the cell expansion system in accordance with embodiments ofthe present disclosure.

FIG. 9A illustrates an example UI showing GUI elements and features forconfiguring display settings of the cell expansion system in accordancewith embodiments of the present disclosure.

FIG. 9B depicts an example data entry window with the UI of FIG. 9A forentering data for configuring display settings of the cell expansionsystem in accordance with embodiments of the present disclosure.

FIG. 9C illustrates an example UI showing configuration aspects fordisplay settings of the cell expansion system in accordance withembodiments of the present disclosure.

FIG. 9D depicts an example UT showing a language selection window forconfiguring display settings of the cell expansion system in accordancewith embodiments of the present disclosure.

FIG. 10A illustrates an example UI providing GUI elements and featuresfor configuring system settings of the cell expansion system inaccordance with embodiments of the present disclosure.

FIG. 10B depicts an example data entry window with the UI of FIG. 10Afor entering data for configuring system settings of the cell expansionsystem in accordance with embodiments of the present disclosure.

FIG. 11 illustrates an example UI for configuring settings of a protocolused with the cell expansion system in accordance with embodiments ofthe present disclosure.

FIG. 12A illustrates an example UI for configuring settings of a customor user-defined task used with the cell expansion system in accordancewith embodiments of the present disclosure.

FIG. 12B depicts a window for selecting a step for adding to a custom oruser-defined task in accordance with embodiments of the presentdisclosure.

FIG. 12C illustrates an example UI for configuring a custom oruser-defined task with multiple steps for use with the cell expansionsystem in accordance with embodiments of the present disclosure.

FIG. 13A depicts an example UI showing a diagram view or window forconfiguring a setting of a process used with the cell expansion systemin accordance with embodiments of the present disclosure.

FIG. 13B illustrates an example data entry window with the example UI ofFIG. 13A for providing data for configuring a protocol for use with thecell expansion system in accordance with embodiments of the presentdisclosure.

FIG. 13C depicts an example window of selection options with the exampleUI of FIG. 13A for configuring a protocol for use with the cellexpansion system in accordance with embodiments of the presentdisclosure.

FIGS. 14A, 14B, 14C, and 14D illustrate a flow diagram depicting theoperational characteristics of a process for modifying the settings of aprotocol for use with the cell expansion system in accordance withembodiments of the present disclosure.

FIGS. 15A and 15B depict a flow diagram illustrating the operationalcharacteristics of a process for configuring aspects of the cellexpansion system in accordance with embodiments of the presentdisclosure.

FIG. 16 illustrates a flow diagram showing the operationalcharacteristics of a process for executing a configured task with thecell expansion system in accordance with embodiments of the presentdisclosure.

FIG. 17 depicts a flow diagram illustrating the operationalcharacteristics of a process for mapping a location of a touch event, ona display area of the cell expansion system, to a UI element inaccordance with embodiments of the present disclosure.

FIGS. 18A, 18B, 18C, and 18D illustrate a flow diagram showing theoperational characteristics of a process for configuring the settings ofa protocol used with the cell expansion system in accordance withembodiments of the present disclosure.

FIGS. 19A, 19B, 19C, and 19D depict a flow diagram illustrating theoperational characteristics of a process for configuring the settings ofa custom or user-defined task used with the cell expansion system inaccordance with embodiments of the present disclosure.

FIGS. 20A and 20B illustrate a flow diagram depicting the operationalcharacteristics of a process for modifying a protocol, from theperspective of a user or operator, for example, for use with the cellexpansion system in accordance with embodiments of the presentdisclosure.

FIG. 21 depicts a flow diagram showing the operational characteristicsof a process for creating a custom or user-defined task, from theperspective of a user or operator, for example, for use with the cellexpansion system in accordance with embodiments of the presentdisclosure.

FIGS. 22A, 22B, and 22C illustrate a flow diagram depicting theoperational characteristics of a process for configuring a protocol foruse with the cell expansion system, from the perspective of a user oroperator, for example, in accordance with embodiments of the presentdisclosure.

FIG. 23 depicts an example data structure associated with a setting of aprotocol step for use with the cell expansion system in accordance withembodiments of the present disclosure.

FIG. 24 illustrates an example processing system of the cell expansionsystem upon which embodiments of the present disclosure may beimplemented.

DETAILED DESCRIPTION

The following Detailed Description provides a discussion of illustrativeembodiments with reference to the accompanying drawings. The inclusionof specific embodiments herein should not be construed as limiting orrestricting the present disclosure. Further, while language specific tofeatures, acts, and/or structures, for example, may be used indescribing embodiments herein, the claims are not limited to thefeatures, acts, and/or structures described. A person of skill in theart will understand other embodiments, including improvements, that arewithin the spirit and scope of the present disclosure.

Embodiments of the present disclosure are generally directed to sterilemethods for loading, growing, and harvesting cells in a hollow fibercell growth chamber of a closed cell expansion system. In furtherembodiments, sterile methods are provided for loading, growing, andharvesting adherent cells, in particular mesenchymal stem cells, in thehollow fiber cell growth chamber of the closed cell expansion system. Aclosed system means that the contents of the system are not directlyexposed to the atmosphere.

With reference now to FIG. 1 , an example of a hollow fiber cell growthchamber 100 which may be used with the present disclosure is shown infront side elevation view. Cell growth chamber 100 has a longitudinalaxis LA-LA and includes cell growth chamber housing 104. In at least oneembodiment, cell growth chamber housing 104 includes four openings orports: IC inlet port 108, IC outlet port 120, EC inlet port 128, and ECoutlet port 132. It should be noted that like elements are representedby like numerals in all of the Figures.

According to embodiments of the present disclosure, fluid in a firstcirculation path enters cell growth chamber 100 through IC inlet port108 at a first longitudinal end 112 of the cell growth chamber 100,passes into and through the intracapillary side (referred to in variousembodiments as the intracapillary (“IC”) side or “IC space” of a hollowfiber membrane) of a plurality of hollow fibers 116, and out of cellgrowth chamber 100 through IC outlet port 120 located at a secondlongitudinal end 124 of the cell growth chamber 100. The fluid pathbetween the IC inlet port 108 and the IC outlet port 120 defines the ICportion 126 of the cell growth chamber 100. Fluid in a secondcirculation path flows in the cell growth chamber 100 through EC inletport 128, comes in contact with the extracapillary side or outside(referred to as the “EC side” or “EC space” of the membrane) of thehollow fibers 116, and exits cell growth chamber 100 via EC outlet port132. The fluid path between the EC inlet port 128 and the EC outlet port132 comprises the EC portion 136 of the cell growth chamber 100. Fluidentering cell growth chamber via the EC inlet port 128 is in contactwith the outside of the hollow fibers 116. Small molecules (e.g., ions,water, oxygen, lactate, etc.) can diffuse through the hollow fibers fromthe interior or IC space of the hollow fiber to the exterior or ECspace, or from the EC space to the IC space. Large molecular weightmolecules such as growth factors are typically too large to pass throughthe hollow fiber membrane, and remain in the IC space of the hollowfibers. The media may be replaced as needed. Media may also becirculated through an oxygenator 232 (FIG. 2 ) to exchange gasses asneeded. Cells can be contained within the first circulation path 202and/or second circulation path 204 as described below, and can be oneither the IC side and/or EC side of the membrane.

The material used to make the hollow fiber membrane may be anybiocompatible polymeric material which is capable of being made intohollow fibers. One material which may be used is a syntheticpolysulfone-based material, according to an embodiment of the presentdisclosure. In order for the cells to adhere to the surface of thehollow fibers, the surface may be modified in some way, either bycoating at least the cell growth surface with a protein such asfibronectin or collagen, or by exposing the surface to radiation. Agamma irradiated polysulfone-based membrane for cell expansion isdescribed in WO 2010/034466. Gamma treating the membrane surface allowsfor attachment of adherent cells without additionally coating themembrane with fibronectin or the like. Bioreactors made of gamma treatedmembranes can be reused.

Referring now to FIG. 2 , a schematic of one possible embodiment of acell expansion system (CES) which may be used with the presentdisclosure is shown. In this embodiment and in all the examples orprotocols below, the cells are grown in the IC space. CES 200 includesfirst fluid circulation path 202 (also referred to as the“intracapillary loop” or “IC loop”) and second fluid circulation path204 (also referred to as the “extracapillary loop” or “EC loop”). Firstfluid flow path 206 is fluidly associated with cell growth chamber 100to form first fluid circulation path 202. Fluid flows into cell growthchamber 100 through IC inlet port 108, through hollow fibers in cellgrowth chamber 100, and exits via IC outlet port 120. Pressure gauge 210measures the pressure of media leaving cell growth chamber 100. Mediaflows through IC circulation pump 212 which can be used to control therate of media flow. IC circulation pump 212 may pump the fluid in afirst direction or second direction opposite the first direction. Exitport 120 can be used as an inlet in the reverse direction. Mediaentering the IC loop may enter through valve 214. As those skilled inthe art will appreciate, additional valves and/or other devices can beplaced at various locations to isolate and/or measure characteristics ofthe media along portions of the fluid paths. Accordingly, it is to beunderstood that the schematic shown represents one possibleconfiguration for various elements of the CES and modifications to theschematic shown are within the scope of the one or more presentembodiments.

With regard to the IC loop, samples of media can be obtained from sampleport 216 or sample coil 218 during operation. Pressure/temperature gauge220 disposed in first fluid circulation path 202 allows detection ofmedia pressure and temperature during operation. Media then returns toIC inlet port 108 to complete fluid circulation path 202. Cellsgrown/expanded in cell growth chamber 100 can be flushed out of cellgrowth chamber 100 into harvest bag 299 through valve 298 orredistributed within the hollow fibers for further growth. This will bedescribed in more detail below. In this example, cells are grown in theIC space.

Fluid in second fluid circulation path 204 enters cell growth chamber100 via EC inlet port 128, and leaves cell growth chamber 100 via ECoutlet port 132. Media in the EC loop is in contact with the outside ofthe hollow fibers in the cell growth chamber 100, thereby allowingdiffusion of small molecules into and out of the hollow fibers.

Pressure/temperature gauge 224 disposed in the second fluid circulationpath 204 allows the pressure and temperature of media to be measuredbefore the media enters the EC space of the cell growth chamber 100.Pressure gauge 226 allows the pressure of media in the second fluidcirculation path 204 to be measured after it leaves the cell growthchamber 100. With regard to the EC loop, samples of media can beobtained from sample port 230 or a sample coil (not shown) duringoperation.

After leaving EC outlet port 132 of cell growth chamber 100, fluid insecond fluid circulation path 204 passes through EC circulation pump 228to oxygenator 232. EC circulation pump 228 may also pump the fluid inopposing directions. Second fluid flow path 222 is fluidly associatedwith oxygenator 232 via oxygenator inlet port 234 and oxygenator outletport 236. In operation, fluid media flows into oxygenator 232 viaoxygenator inlet port 234, and exits oxygenator 232 via oxygenatoroutlet port 236. Oxygenator 232 adds oxygen to and removes bubbles frommedia in the CES. In various embodiments, media in second fluidcirculation path 204 is in equilibrium with gas entering oxygenator 232.The oxygenator 232 can be any appropriately sized oxygenator or gastransfer device known in the art. Air or gas flows into oxygenator 232via filter 238 and out of oxygenator or gas transfer device 232 throughfilter 240. Filters 238 and 240 reduce or prevent contamination ofoxygenator 232 and associated media. Air or gas purged from the CES 200during portions of a priming sequence can vent to the atmosphere via theoxygenator 232.

In the configuration depicted for CES 200, fluid media in first fluidcirculation path 202 and second fluid circulation path 204 flows throughcell growth chamber 100 in the same direction (a co-currentconfiguration). The CES 200 can also be configured to flow in acounter-current conformation.

In accordance with at least one embodiment, media, such as cells (frombag 262), and fluid media from bag 246 can be introduced to first fluidcirculation path 202 via first fluid flow path 206. Fluid containers, ormedia bags, 244 (e.g., Reagent) and 246 (e.g., IC Media) may be fluidlyassociated with either first fluid inlet path 242 via valves 248 and250, respectively or second fluid inlet path 274 via valves 270 and 276.First and second sterile sealable input priming paths 208 and 209 areprovided. Air removal chamber (ARC) 256 is fluidly associated with firstcirculation path 202. The air removal chamber 256 may include one ormore ultrasonic sensors including an upper sensor 1268 and lower sensor1264 to detect air, a lack of fluid, and/or a gas/fluid interface, e.g.,an air/fluid interface, at certain measuring positions within the airremoval chamber 256 (see FIG. 6 ). For example, ultrasonic sensors maybe used near the bottom and/or near the top of the air removal chamber256 to detect air, fluid, and/or an air/fluid interface at theselocations. Embodiments provide for the use of numerous other types ofsensors without departing from the spirit and scope of the presentdisclosure. For example, optical sensors may be used in accordance withembodiments of the present disclosure. Air or gas purged from the CES200 during portions of the priming sequence or other protocols can ventto the atmosphere out air valve 260 via line 258 that is fluidlyassociated with air removal chamber 256.

Fluid container 262 (e.g., Cell Inlet Bag (or Saline Priming Fluid forpriming air out of the system)) is fluidly associated with the firstfluid circulation path 202 via valve 264.

EC media (from bag 268) or wash solution (from bag 266) may be added toeither the first or second fluid flow path. Fluid container 266 may befluidly associated with valve 270 that is fluidly associated with firstfluid circulation path 202 via distribution valve 272 and first fluidinlet path 242. Alternatively, fluid container 266 can be fluidlyassociated with second fluid circulation path 204 via second fluid inletpath 274 and second fluid flow path 284 by opening valve 270 and closingdistribution valve 272. Likewise, fluid container 268 is fluidlyassociated with valve 276 that may be fluidly associated with firstfluid circulation path 202 via first fluid inlet path 242 anddistribution valve 272. Alternatively, fluid container 268 may befluidly associated with second fluid inlet path 274 by opening valve 276and closing valve distribution 272.

An optional heat exchanger 252 may be provided for media reagent or washsolution introduction.

In the IC loop, fluid is initially advanced by the IC inlet pump 254. Inthe EC loop, fluid is initially advanced by the EC inlet pump 278. Anair detector 280, such as an ultrasonic sensor, may also be associatedwith the EC inlet path 284.

In at least one embodiment, first and second fluid circulation paths 202and 204 are connected to waste line 288. When valve 290 is opened, ICmedia can flow through waste line 288 and to waste bag 286. Likewise,when valve 292 is opened, EC media can flow through waste line 288 towaste bag 286.

Cells can be harvested via cell harvest path 296. Here, cells from cellgrowth chamber 100 can be harvested by pumping the IC media containingthe cells through cell harvest path 296 and valve 298 to cell harvestbag 299.

Various components of the CES 200 can be contained or housed within anincubator machine or housing 304 (FIG. 3 ), wherein the incubatormaintains cells and media at a desirable temperature.

With reference now to FIG. 3 , an embodiment of a CES 200 is shown. TheCES 200 includes a cell expansion housing or machine 304 that comprisesa hatch or closable door 308 for engagement with a back portion 312 ofthe cell expansion machine 200. An interior space 316 within the cellexpansion machine 304 includes features adapted for receiving andengaging a premounted fluid conveyance assembly 320. The premountedfluid conveyance assembly 320 is detachably-attachable to the cellexpansion machine 200 to facilitate relatively quick exchange of a newor unused premounted fluid conveyance assembly 320 at a cell expansionmachine 200 for a used premounted fluid conveyance assembly 320 at thesame cell expansion machine 200. Advantageously, a single cell expansionmachine 304 can be operated to grow or expand a first set of cells usinga first premounted fluid conveyance assembly 320, and thereafter, usedto grow or expand a second set of cells using a second premounted fluidconveyance assembly 320 without needing to be sanitized betweeninterchanging the first premounted fluid conveyance assembly 320 for thesecond premounted fluid conveyance assembly 320. The premounted fluidconveyance assembly includes the bioreactor 100 and the oxygenator 232.Tubing guide slots are shown as 612 for receiving various media tubingconnected to premounted fluid conveyance assembly 320.

Referring now to FIG. 4 , the back portion 312 of a cell expansionmachine 304 is shown prior to detachably-attaching a premounted fluidconveyance assembly 320. For clarity, the closable door 308 (shown inFIG. 3 ) is omitted from FIG. 4 . The back portion 312 of the cellexpansion machine 304 includes a number of different structures forworking in combination with elements of a premounted fluid conveyanceassembly 320. More particularly, the back portion 312 of the cellexpansion machine 304 includes a plurality of peristaltic pumps forcooperating with pump loops 404 (FIG. 5 ), including the IC circulationpump 212, the EC circulation pump 228, the IC inlet pump 254, and the ECinlet pump 278. In addition, the back portion 312 of the cell expansionmachine 104 includes a plurality of valves, including the IC circulationvalve 214, the reagent valve 248, the IC media valve 250, the airremoval valve 260, the cell inlet valve 264, the wash valve 270, thedistribution valve 272, the EC media valve 276, the IC waste valve 290,the EC waste valve 292, and the harvest valve 298. Several sensors arealso associated with the back portion 312 of the cell expansion machine304, including the IC outlet pressure sensor 210, the combination ICinlet pressure and temperature sensors 220, the combination EC inletpressure and temperature sensors 224, and the EC outlet pressure sensor226. Also shown is the optical sensor 616 for the air removal chamber256.

Referring still to FIG. 4 , a shaft or rocker control 604 for rotatingthe bioreactor 100 is shown. Shaped fitting 608 associated with theshaft 604 allows for proper alignment of a shaft access aperture 324(FIG. 5 ) of the tubing-organizer 300 of the premounted conveyanceassembly with the back portion 312 of the cell expansion machine 304.Rotation of rocker control 604 imparts rotational movement to shaftfitting 508 (FIG. 5 ) and bioreactor 100. Thus, when an operator of theCES 200 attaches a new or unused premounted fluid conveyance assembly320 to the cell expansion machine 304, the alignment is a relativelysimple matter of properly orienting the shaft access aperture 324 of thepremounted fluid conveyance assembly 320 with the shaped fitting 608.

Referring now to FIG. 5 , a perspective view of a detachably-attachablepremounted fluid conveyance assembly 320 is shown. The premounted fluidconveyance assembly 320 is detachably-attachable to the cell expansionhousing 304 to facilitate relatively quick exchange of a new or unusedpremounted fluid conveyance assembly 320 at a cell expansion machine 304for a used premounted fluid conveyance assembly 320 at the same cellexpansion machine 304. As shown in FIG. 5 , the bioreactor 100 isattached to a bioreactor coupling that includes a shaft fitting 508. Theshaped fitting 508 includes one or more shaft fastening mechanisms, suchas a biased arm or spring member 512 for engaging a shaft (shown in FIG.4 ) of the cell expansion machine 304.

Referring still to FIG. 5 , the premounted fluid conveyance assembly 320typically includes tubing 408 and various tubing fittings 412 to providethe fluid paths shown in FIG. 2 . Pump loops 404 are also provided forthe pump. Although the various media are typically provided at the sitewhere the cell expansion machine 304 is located, the premounted fluidconveyance assembly 320 typically includes sufficient tubing length toextend to the exterior of the cell expansion machine 304 and to enablewelded connections to tubing associated with the media bags.

The air removal chamber or ARC will now be described with respect withFIG. 6 . In accordance with at least one embodiment, the air removalchamber 256 is mounted in a substantially vertical orientation on thepremounted fluid conveyance assembly 320, such that air or gas bubbleswithin the fluid rise upward away from the bottom 1212 toward the ventaperture 1224 preferably located at the top 1228 along the verticaldirection of the air removal chamber 256, or at least vertically abovethe fluid entrance aperture 1220 and fluid exit aperture 1236.

Referring again to FIG. 6 in at least one embodiment a plurality offluid level sensors is used in combination with the air removal chamber256. In at least one embodiment, the sensors are located on the cellexpansion machine 304 at 616. More particularly, while the air removalchamber 256 is connected to a premounted fluid conveyance assembly 320that can be detachably-attached to the cell expansion machine 304, thefluid level sensors for the air removal chamber 256 form part of thecell expansion machine 304.

In accordance with at least one embodiment, at least two sensors areused with the air removal chamber 256 to provide “high” and “low” fluidlevel sensing capability. Accordingly, operating protocol for the CES100 includes monitoring the fluid level within the air removal chamber256 and adjusting the pumping rate of the peristaltic pumps as necessaryto maintain an appropriate fluid level within the fluid containmentchamber 1208 of the air removal chamber. This operating protocol mayinclude increasing or decreasing the pumping rates associated with pumpson either one or both the upstream and downstream sides of the airremoval chamber 256. The ARC as described below also functions as a stopindication for various protocols.

In at least one embodiment, a first fluid level sensor 1264 (or lowlevel fluid sensor) is situated to detect a fluid level in the airremoval chamber 256 at a level of approximately ¼ full, and a secondfluid level sensor 1268 (or high level fluid sensor) is situated todetect a fluid level in the air removal chamber 256 at a level ofapproximately ¾ full. The position of the fluid level sensors 1264 and1268 allow the fluid level within the air removal chamber 256 to beadjusted to ensure that air does not pass though the fluid exit aperture1236 and enter the fluid exit tube 1240 at the bottom 1212 of the airremoval chamber 256 because of too low a fluid level, and that fluiddoes not exit through vent aperture 1224 located at the top 1228 of theair removal chamber 256 because of too high a fluid level.

As will be recognized by those of skill in the art, any number of fluidcontainers (e.g., media bags) can be fluidly associated with the CES inany combination.

Protocols will now be described with respect to the schematic describedin FIG. 2 , in accordance with embodiments of the present disclosure.

The following is a definition section for the Protocols described below.Points A through H on the schematic of FIG. 2 are also described in thedefinition section below. In the protocols or examples described thedefinition section may be referenced for various descriptions.

Protocols Parameter Definitions

Parameter Value Explanations VOLUME (mL) V_(ICL) 189.1 IC Loop Volume,V_(BRIC) + 2V_(BRICH) + V_(EF) V_(ECL) 305.6 EC Loop Volume, V_(BREC) +V_(GH) V_(ICBL) 29.3 Volume from bags to IC Loop, ARC volume is assumedto be 10 mL, inlet bag length assumed to be 3 mL V_(ECBL) 18.5 Volumefrom bags to EC Loop, inlet bag length assumed to be 3 mL V_(ICE) 218.4IC Exchange volume = V_(ICL) + V_(ICBL) V_(ECE) 324.1 EC Exchange volume= V_(ECL) + V_(ECBL) V_(ABI) 9 Point “A” on FIG. 2 to Bioreactor inlet(includes header volume), excludes value directly from ARC to T-junctionV_(ABO) 42.1 Point “A” of FIG. 2 to Bioreactor outlet (includes headervolume), excludes value directly from ARC to T-junction V_(AB) 32.6Volume from point “A” to point “B” of FIG. 2 V_(CD) 3.8 Volume frompoint “C” to point “D” of FIG. 2 V_(ARC) 11.1 Volume used to flush ARCcontents into IC Loop = V_(ARCA) + V_(ARCBS) V_(BRIC) 138 Volume of theIC side of bioreactor, excludes headers V_(BRICH) 4.5 Volume of ICheader V_(EF) 42.1 Volume from Point “E” to Point “F”IC loop of FIG. 2excluding bioreactor V_(BREC) 266 Volume of the EC side of thebioreactor V_(GH) 39.6 Volume from Point “G” to Point “H”EC loop of FIG.2 excluding bioreactor V_(FA) 37.6 Volume from Point “F” to Point “A” ICloop of FIG. 2 excluding bioreactor V_(EA) 4.5 Volume from Point “E” toPoint “A” IC loop of FIG. 2 excluding bioreactor V_(ARCA) 4.1 Volumefrom the bottom sensor of the ARC to Point “A” of FIG. 2 V_(ARCBS) 7Volume of ARC between sensors V_(ARCF) 2 Volume to fill above ARC topsensor V_(FTO) 40.2 (1 + LP %/100) * V_(ICBL) + 5 mL V_(PICBR) 157.4Line volume being primed for IC side of bioreactor V_(PICCP) 33 Linevolume being primed for IC Circulation pump V_(PECCP) 4.6 Line volumebeing primed for EC Circulation pump V_(PREL) 20.9 Line volume beingprimed for Reagent/EC Media loop V_(PWIL) 20 Line volume being primedfor Wash/IC Media loop V_(PECBR) 308.3 Line volume being primed forDist. Valve and EC bioreactor V_(ICPARC) 6.5 Volume from the bottom ofthe ARC to the IC inlet pressure pod includes pressure pod. V_(MTBS)18.6 Maximum volume to bottom ARC sensor V_(MTTS) 25.6 Maximum volume totop ARC sensor (V_(MTBS) + V_(ARCBS)) V_(MTECS) 33.1 Maximum volume toEC fluid sensor V_(ABO) % 82.4% =V_(ABO) * 100/(V_(ABI) + V_(ABO)) AB %17.2% =V_(AB) * 100/V_(ICL) CD % 1.2% =V_(CD) * 100/V_(ECE) SP % 20%Pump error to be added to a volume from a small pump LP % 20% Pump errorto be added to a volume from a large pump POINTS ON HYDRAULIC LAYOUT ASSHOWN ON FIG. 2 A T-junction immediately below the ARC where IC fluidenters the IC loop. B Location in the IC Loop where fluid leaves theloop on its way to the Waste Bag C T-junction where EC fluid enters theEC loop. D Location in the EC Loop where fluid leaves the loop on itsway to the Waste Bag. E Location in the IC Loop where the line meets theIC Inlet header. F Location in the IC Loop where the line meets the ICOutlet header. G Location in the EC Loop where the line meets the ECInlet of the bioreactor. H Location in the EC Loop where the line meetsthe EC Outlet of the bioreactor. PUMP RATES (mL/min) Q_(ICA) IC InletPump rate (mL/min) Q_(ICC) IC Circulation Pump rate (mL/min) Q_(ECA) ECInlet Pump rate (mL/min) Q_(ECC) EC Circulation Pump rate (mL/min)Q_(ECCM) 30 EC Circulation Pump rate to keep EC Loop well mixed Q_(ECCE)250 EC circulation pump rate to equilibrate EC loop Q_(ICCM) 20 ICCirculation Pump rate to keep IC Loop well mixed while preventing airfrom entering the bioreactor fibers (Q_(ICC) + Q_(ICA) = Q_(ICCM))Q_(ICCE) 100 IC circulation pump rate to equilibrate IC loop Q_(ECAUF)50 EC Inlet rate to create ultra filtration Q_(ARC) 200 Max flow ratethat does not cause air entrapment when ARC fluid level is at low levelsensor when running Q_(FARC) 40 IC Inlet pump rate (mL/min) used to fillARC. UFR₄₀₀ 60 Negative UFR required to insure zero TMP at thebioreactor outlet when in co- current flow and when IC Inlet rate = 400mL/min and EC waste valve is closed. TIME (min) T_(CM) 10 Time toequilibrate (condition) media Note: For all examples the initialposition of the bioreactor 100 to define rocker control motion is asshown in FIG. 3 or parallel to the horizon.Protocol 1: High Flux Cell Load in Bioreactor Example

In an embodiment, this protocol is to load the cells from cell inlet bag262 into bioreactor 100 until the bag 262 is empty. This is a high fluxload at a medium flow rate.

V_(ICBL), is the volume from the bags such as cell inlet bag 262 to theIC loop 202. In this example, the V_(ICBL) is 29.3 mL assuming thevolume of the air removal chamber (ARC) is 10 mL and the inlet bag 262length, such as cell inlet bag 262, is 3 mL.

For a high flux cell load, V_(FTO) of air is needed in the cell inletbag. V_(FTO) is defined as (1+LP %/100)*V_(ICBL)+5 mL. In this example,it is 40.2 mL. LP % is a percentage related to pump error volume and inthis example may be 20%.

The High Flux Load Protocol conditions are:

1) Valve 264 is open.

2) Inlet Pump 254 pumps at 50 mL/min (can be within 20 to 100 mL/minrange).

3) IC circulation pump 212 and EC inlet pump 278 are off.

4) EC circulation pump 228 is set at Q_(ECCM) which is a rate selectedto keep EC loop well mixed which in this example is 30 mL/min.

5) IC Valve 290 is open to waste.

6) The bioreactor 100 is rotated using the rocker control from −90° to180° with 1 second rest at end points to distribute cells. Alternativelythe bioreactor can be fixed.

7) The high flux cell load is stopped when air is detected in the airremoval chamber or ARC by the lower air sensor 1264.

8) ARC valve 260 is open to vent ARC air to atmosphere.

9) The ARC is then filled with media (either reagent, IC media or washsolution by pump 254 to upper sensor 1268). IC media may be at least 60mL of media with protein.

10) Cells are chased from the ARC by the fill media of item 9) above tothe bioreactor 100 with larger chase volumes spreading the cells towardthe IC outlet 120.

11) The chase is stopped at a selected IC volume which in this exampleis 47 mL.

The following is a brief summary of Protocol High Flux Load with chasestep.

Protocol 1 High Flux Load

Purpose of protocol: Loads cells into the bioreactor from the cell inletbag until the bag is empty. This protocol does not use IC circulation todistribute the cells.

Step 1: Load Bioreactor

Purpose of Step: Loads the cells from the cell inlet bag into thebioreactor.

Precondition: Need at least V_(FTO) of air in cell inlet bag.

Input Range IC Source Cell Inlet EC Source None Stop Condition ARC StopIC Inlet Rate Default: 50 (mL/min) Range: 20 to 100 mL/min ICCirculation Rate Default: 0 (mL/min) EC Inlet Rate Default: 0 (mL/min)EC Circulation Rate Default: Q_(ECCM) (mL/min) Range: 10 to 300 mL/minOutlet EC Waste Rocker Control On or in motion (−90°, 180, 1 sec) (Def)Range: full range Fixed (0°) Range: full range (deg) Output: IC volumerate as defined by Stop Condition Output: EC volume N/A Output:Remaining ARC Stop as defined by Stop Condition time of stepStep 2: Chase to BioreactorPurpose of Step: Chases the cells from the ARC to the bioreactor. Largerchase volumes spread the cells and move them towards the IC outlet.Precondition: Fill ARC

Input Range IC Source Reagent IC Media (Default) Wash EC Media EC SourceNone Stop Condition IC volume: (V_(ARCA) + V_(ARCBS) + V_(EA))*3 Range:1 to 200 mL IC Inlet Rate Default: Same as Step 1 (mL/min) ICCirculation Rate Default: Same as Step 1 (mL/min) EC Inlet Rate Default:0 (mL/min) EC Circulation Rate Default: Same as Step 1 (mL/min) OutletEC Waste Rocker Control Same as Step 1 Output: IC volume Volume asdefined by Stop Condition Output: EC volume N/A Output: RemainingCountdown in minutes as defined by time of step Stop ConditionProtocol 2: Load Cells into Bioreactor with Circulation Example

In an embodiment, this alternative protocol loads the cells from the ICinlet bag 262 until it is empty to the bioreactor 100. It uses the ICcirculation loop 202 for the load. The cell inlet bag contains at leastV_(FTO) of air. The IC circulation pump 212 permits load from both theinlet 108 and outlet 120 of bioreactor 100.

The conditions for the Protocol Load Cells into Bioreactor withCirculation are:

1) Valve 264 is open.

2) Inlet pump 254 operates at 50 mL/min within a range of 200 to 100mL/min.

3) IC circulation rate using pump 212 is V_(ICL)/min−Q_(ICA)

V_(ICL), is the IC loop 202 volume orV _(BRIC)+2V _(BRICH) +V _(EF)V_(BRIC) is the volume of the IC side of bioreactor 100 excludingheaders. V_(BRICH) is the volume of the headers. V_(EF) is the volume ofthe IC loop from E to F on FIG. 2 excluding the bioreactor. Q_(ICA) isthe inlet pump rate. The range for the IC circulation rate is from 20 to300 mL/min and depends on the IC inlet rate. In this example it is 139mL/min.4) EC inlet is 0 with default Q_(ECCM) in a range from 10 to 300 mL/min.5) The EC circulation rate is Q_(ECCM), for example 30 mL/min.6) The outlet the EC waste through valve 292.7) Rocker control for the bioreactor 100 is −90° to 180° for 1 secondstops at the ends of rotation or optionally the bioreactor may be fixed.8) The stop condition is air detection by the ARC by the lower airsensor 1264.9) After stop condition ARC is filled with desired media to upper sensor1268 and chase liquid chases the cells from the ARC to the loop. Thestop condition for chase is the IC volume (V_(ARCA)+V_(ARCBS))*2 in arange from 1 to 100. V_(ARCA) is the volume from the ARC to point A onFIG. 2 and V_(ARCBS) is the volume of the ARC between sensors 1268 and1264.10) To load the cells from the IC loop the IC circulation rate is−V_(ABO)% of Q_(ICA). −V_(ABO)% is V_(ABO)*100/V_(ABI)+V_(ABO). V_(ABO)is the volume from point A to the bioreactor 100 outlet (point F) and inthis example is 42.1 mL. Q_(ICA) is the inlet pump rate as describedabove. V_(ABI) is the volume from point A to inlet 108 with V_(ABO)being the volume from point A to outlet 120.11) The stop condition for the load is the IC volume 1.5×V_(EF). Therange is 0.5 V_(EF) to 2.0 V_(EF). V_(EF) is the volume of the IC loop202 from point E to F excluding the bioreactor.

Below is a summary of the circulation load.

Protocol 2 Load with Circulation

Purpose of protocol: Loads the cells into the bioreactor from the cellinlet bag until the bag is empty, and uses IC circulation to distributethe cells.

Step 1: Load IC Loop

Purpose of Step: Loads the cells into the system.

Precondition: Need at least V_(FTO) of air in cell inlet bag.

Input Range IC Source Cell Inlet EC Source None Stop Condition ARC StopIC Inlet Rate Default: 50 (mL/min) Range: 20 to 100 mL/min ICCirculation Rate Default: V_(ICL)/min − Q_(ICA) (mL/min) Range: 20 to300 mL/min EC Inlet Rate Default: 0 (mL/min) EC Circulation RateDefault: Q_(ECCM) (mL/min) Range: 10 to 300 mL/min Outlet EC WasteRocker Control On (−90°, 180°, 1 sec) (Def) Range: Full Range (deg,time) Fixed (0°) Range: full range (deg) Output: IC volume rate asdefined by Stop Condition Output: EC volume N/A Output: Remaining ARCstop as defined by Stop Condition time of step Note: Q_(ICA)t + Q_(ICC)t= nV_(ICL)Step 2: ARC ChasePurpose of Step: Chases the cells from the ARC into the IC loop.Precondition: Fill ARC

Input Range IC Source Reagent IC Media (Default) Wash EC Media EC SourceNone Stop Condition IC volume: (V_(ARCA) + V_(ARCBS))*2 Range: 1 to 100IC Inlet Rate Default: Same as Step 1 (mL/min) IC Circulation RateDefault: Same as Step 1 (mL/min) EC Inlet Rate Default: 0 (mL/min) ECCirculation Rate Default: Same as Step 1 (mL/min) Outlet EC Waste RockerControl Same as Step 1 Output: IC volume Volume as defined by StopCondition Output: EC volume N/A Output: Remaining Countdown in minutesor manual stop as time of step defined by Stop ConditionStep 3: Load BioreactorPurpose of Step: Chases the cells from the IC loop into the bioreactor.

Input Range IC Source Reagent IC Media (Default) Wash EC Media EC SourceNone Stop Condition IC volume: 1.5 × V_(EF) (Default) Range: 0.5V_(EF)to 2.0V_(EF) IC Inlet Rate Default: Same as Step 1 (mL/min) ICCirculation Rate Default: −V_(ABO) % of Q_(ICA) (mL/min) EC Inlet RateDefault: 0 (mL/min) EC Circulation Rate Default: Same as Step 1 (mL/min)Outlet EC Waste Rocker Control Same as Step 1 Output: IC volume Volumeas defined by Stop Condition Output: EC volume N/A Output: RemainingCountdown in minutes as defined by time of step Stop ConditionProtocol 3: Bone Marrow Washout Example

In an embodiment, this protocol is to remove non-attached/non-adheredcells from the bioreactor. It is for 25 mL to 62 mL bone marrow loadthough it could be used for load above 10 mL. The bone marrow washoutgenerally follows bone marrow load. It can also be a wash out protocolwhen the bioreactor is packed with a large number of cells though thisprotocol is typically done after an initial load. The types of cellsremoved include red blood cells, platelets and non-adherent bone marrowcells.

The protocol includes the following:

1) IC media introduced through valve 250. This may be approximately 500mL with protein. Optionally wash or EC media could be introduced.

2) EC media is generally media without protein introduced through valve276. Optionally wash or IC media could be introduced on EC side.

3) IC inlet rate (mL/min) through pump 254 is expressed as follows:

$= | \begin{matrix}{0,} & {0 < t \leq t_{1}} \\{{20 + {( {( {Q/2} ) - 20} ) \times ( {( {t - t_{1}} )/t_{1}} )}},} & {t_{1} < t \leq t_{2}} \\{{( {Q/2} ) + {( {Q/2} ) \times ( {( {t - t_{2}} )/( {t_{3} - t_{2}} )} )}},} & {t_{2} < t \leq t_{3}} \\{0,} & {t_{3} < t}\end{matrix} $

In this example the maximum is 100 mL/min.

4) IC circulation rate is expressed as follows: −AB %*Q_(ICA)AB %=V _(AB)*100/V _(ICL)V_(AB)=volume from point A to B on FIG. 2V_(ICL)=IC loop volume5) EC inlet rate (mL/min)

$= | \begin{matrix}{20 + {( {( {Q/2} ) - 20} ) \times ( {t - t_{1}} )}} & {0 < t \leq t_{1}} \\{Q/2} & {t_{1} < t \leq t_{2}} \\{( {Q/2} ) - {( {Q/2} ) \times ( {( {t - t_{2}} )/( {t_{3} - t_{2}} )} )}} & {t_{2} < t \leq t_{3}} \\{0,} & {t_{3} < t}\end{matrix} $6) The parameters for both the IC inlet and EC inlets rates are definedin the table following:

Parameter Equation V User input − Total IC + EC volume to be pumped(mL). Q User input − Maximum IC inlet rate (mL/min). Q > 40 mL/min. t₁(minutes) = V × ((2 × (Q − 40))/(3 × Q² − 40 × Q − 1600)) t₂ (minutes) =2 × t₁; t₃ (minutes) = (5/2) × ((Q − 32)/(Q − 40)) × t₁7) EC circulation rate (mL/min)=Q_(ECCM) of a range from 10 to 300mL/min. Q_(ECCM)=rate to keep EC loop well mixed in this example 30mL/min.8) Rocker control for bioreactor 100 is on with −90°, 180°, for 1 secondpause at the ends.9) The stop condition in this example is an inlet volume of 1000 mL witha range from 400 to 4000.10) Maximum flow rate of output washout is 100 mL in range from 80 to200.

Summary of the protocol is below.

Protocol 3 Bone Marrow Washout

Purpose of protocol: Meant for use following a bone marrow load (25 mLto 62 mL) and attachment phase, this protocol is recommended to removeany non-attached/non-adhered cells from the bioreactor. This is also auseful washout protocol for any occasion when the bioreactor is packedwith a similar large number of cells. For bone marrow loads of 10 mL orless, Protocol Aggressive Washout is recommended. For bone marrow loadsbetween 10 mL to 25 mL, this protocol is optional but may not berequired.Step 1: Bone Marrow Washout

Input Range IC Source IC Media(Default) Wash EC Media EC Source IC MediaWash EC Media (Default) Stop Condition Volume = 1000 Range: 400 to 4000Washout Parameters Maximum Flow Rate (MFR) = 100 Range: 80 to 200 ICInlet Rate (mL/min) $\quad\begin{matrix}{= | \begin{matrix}{0,} & {0 < t \leq t_{1}} \\{{20 + {( {( {Q\text{/}2} ) - 20} ) \times ( {( {t - t_{1}} )\text{/}t_{1}} )}},} & {t_{1} < t \leq t_{2}} \\{{( {Q\text{/}2} ) + {( {Q\text{/}2} ) \times ( {( {t - t_{2}} )\text{/}( {t_{3} - t_{2}} )} )}},} & {t_{2} < t \leq t_{3}} \\{0,} & {t_{3} < t}\end{matrix} } \\{{where}\mspace{14mu}{parameters}\mspace{14mu}{are}\mspace{14mu}{defined}\mspace{14mu}{in}\mspace{14mu}{table}\mspace{14mu}{{following}.}}\end{matrix}$ IC Circulation Rate Value: −AB% * Q_(ICA) (mL/min) ECInlet Rate (mL/min) $= | \begin{matrix}{20 + {( {( {Q\text{/}2} ) - 20} ) \times ( {t\text{/}t_{1}} )}} & {0 < t \leq t_{1}} \\{Q\text{/}2} & {t_{1} < t \leq t_{2}} \\{( {Q\text{/}2} ) + {( {Q\text{/}2} ) \times ( {( {t - t_{2}} )\text{/}( {t_{3} - t_{2}} )} )}} & {t_{2} < t \leq t_{3}} \\{0,} & {t_{3} < t}\end{matrix} $ EC Circulation Rate Default: Q_(ECCM) (mL/min)Range: 10 to 300 mL/min Outlet IC Waste Rocker On (−90°, 180°, 1 sec)Range: full range (deg, time) Output: IC volume Volume as defined bystop condition Output: EC volume Volume as defined by stop conditionOutput: Remaining Countdown in minutes as defined by stop time of stepcondition

Parameter Equation V User input − Total IC + EC volume to be pumped(mL). Q User input − Maximum IC inlet rate (mL/min). Q > 40 mL/min. t₁(minutes) = V × ((2 × (Q − 40))/(3 × Q² − 40 × Q − 1600)) t₂ (minutes) =2 × t₁; t₃ (minutes) = (5/2) × ((Q − 32)/(Q − 40)) × t₁Protocol 4: Aggressive Washout for Bone Marrow Loads Below 10 mL Example

In an embodiment, this protocol produces a small amount ultrafiltrationinto the hollow fiber of the bioreactor membrane 116 across the entirefilter length. The purpose of the protocol is to remove non-adherentcells from the bioreactor.

The protocol includes:

1) IC source is IC media introduced through valve 250 by pump 254.Alternatively the IC source could be reagent, wash, or EC media. The ICmedia may be media with protein estimated in this example to be about500 mL.

2) EC source is EC media introduced through valve 276 by pump 278.Alternatively the EC source could be reagent, IC media, or wash. Thismay be media without protein.

3) IC pump 254 is set at approximately 260 mL/min inlet rate from arange of 50 to 500 mL/min.

4) IC circulation rate is −AB %*Q_(ICA), in this example, −45 mL/min.

5) EC inlet rate is 40 mL/min from a range of 0 to 100 mL/min.

6) EC circulation rate is Q_(ECCM) or the rate to keep the loop wellmixed from a range of 10 to 300 mL/min, in this example 30 mL/min.

7) The IC source goes to waste.

8) The rocker control for the bioreactor 100 may be set at −90% to 180%for 1 second pause at the ends of the range of motion or optionallycould be fixed.

9) The stop condition for the process may be based on time such as up to60 minutes; IC volume as defined in the Bone Marrow Washout which mayrange from is from 0 to 4000 mL range; or the number of IC exchanges ornumber of times the IC source fluid is circulated. The number of ICexchanges may be 2.5 from a range of 0.5 to 5.0

Summary of the protocol is below.

Protocol 4 Aggressive Washout

Purpose of protocol: Removes non-adherent cells from the bioreactor.This protocol imposes a small ultrafiltration into the fiber across theentire fiber length.

Step 1: Aggressive Washout

Input Range IC Source Reagent IC Media (Default) Wash EC Media EC SourceReagent IC Media Wash EC Media (Default) Stop Condition Time: (1 min)Range: 0.1 to 60 min IC volume: (V_(ICE)) Range: 1 to 4000 mL # of ICexchanges: 2.5 (default) Range 0.5 to 5.0 IC Inlet Rate Default: 260(mL/min) Range: 50 to 500 mL/min IC Circulation Rate Default: −AB % *Q_(ICA) (mL/min) EC Inlet Rate Default: 40 (mL/min) Range: 0 to 100mL/min EC Circulation Rate Default: Q_(ECCM) (mL/min) Range: 10 to 300mL/min Outlet IC Waste Rocker Control On (−90°, 180°, 1 sec) (Def)Range: Full Range (deg, time) Fixed (0°) Range: Full range (deg) Output:IC volume Volume as defined by Stop Condition Output: EC volume Volumeas defined by Stop Condition Output: Remaining Countdown in minutes asdefined by time of step Stop ConditionProtocol 5: IC or EC Washout Example

In an embodiment, this protocol is to replace media while growingadherent cells. The protocol washes out cellular debris and non-adherentcells. The replacement volume is the number of IC and EC exchanges to beperformed or IC or EC volume exchanged.

V_(ICE) (IC exchange volume) equals IC loop volume plus volume frommedia, reagent or wash bags to IC loop.

V_(ECE) (EC exchange volume) equals EC loop volume plus volume frommedia, reagent or wash bags to EC loop.

The protocol includes the following.

1) The IC source is IC media introduced through valve 250 by pump 254.Reagent, EC media, or wash solution may optionally be used. The IC mediamay be media with protein. In this example the volume may be at least550 mL.

2) The EC source is EC media introduced through valve 276 by pump 278.Reagent, IC media, or wash solution may optionally be used. The EC mediamay be media without protein. In this example the volume may be at least810 mL.

3) The IC inlet rate is Q_(ECA) (number of IC Exc*V_(ICE))/(number of ECExc*V_(ECE))

Q_(ECA)=EC inlet pump rate

V_(ICE)=IC exchange volume which in this example is 218.4 mL.

V_(ECE)=EC exchange volume which in this example is 324.1 mL.

4) IC circulation rate is −AB %*Q_(ICA)

AB %=V_(AB) (volume from point A to Bin FIG. 2 )*100/V_(ICL). V_(ICL),is IC loop volume.

Q_(ICA)=IC inlet pump 254 rate

5) The EC inlet rate is the lesser of Q₁₀₀ or Q_(MAX) whereQ ₁₀₀=100(number of EC Exc*V _(ECE))/(number of IC Exc*V _(ICE)) andQ_(MAX)=3006) The EC circulation rate is −CD %*Q_(ECA). CD %=V_(CD) (or volume frompoint C to D, in this example 3.8 mL)*100/V_(ECE).7) The outlet for the media or washout fluid is either the IC, EC, orboth waste 286.8) The rocker control for the bioreactor 100 is −90° to 180° with 1second pause at the end of the range of motion. Or alternatively, thereis no rocker control motion.9) The stop condition to end the process includes the number of ICexchanges (Exc.) which may be 2.5 or optionally within a range from 0.5to 5. The stop condition also includes the number of EC exchanges whichmay be 2.5 or optionally within a range from 0.5 to 5.

A summary of this protocol is as follows.

Protocol 5 IC or EC Washout

Purpose of protocol: Meant for use when growing adherent cells toreplace the media in both the IC loop and EC loop. This protocolprovides some washout of cellular debris and non-adherent cells. Thereplacement volume is specified as the number of IC and EC exchanges tobe performed.Calculations:

-   -   One IC exchange volume (V_(ICE)) is equal to the IC Loop Volume        plus the volume from bags to IC loop.    -   One EC exchange (V_(ECE)) is equal to the EC Loop Volume plus        the volume from bags to EC Loop.        Step 1: Washout

Input Range IC Source Reagent IC Media (Default) Wash EC Media EC SourceReagent IC Media Wash EC Media (Default) Stop Condition # of ICExchanges: 2.5 (default) range: 0.5-5.0 # of EC Exchanges: 2.5 (default)range: 0.5-5.0 IC Inlet Rate Value: Q_(ECA) (# of IC Exc. * V_(ICE))/(#of (ml/min) EC Exc. * V_(ECE)) IC Circulation Rate Value: −AB % *Q_(ICA) (ml/min) EC Inlet Rate Initial value: the lesser of Q₁₀₀ orQ_(max); (ml/min) where Q₁₀₀ = 100 (# of EC Exc. * V_(ECE))/(# of ICExc. * V_(ICE)) and Q_(max) = 300. EC Circulation Rate Value: −CD % *Q_(ECA) (ml/min) Outlet EC Waste IC Waste IC&EC Waste (default) RockerControl On (−90°, 180°, 1 sec) (Def) Range: full range (deg, time) Fixed(0°) Range: Full range (deg) Output: IC volume Volume as defined by StopCondition Output: EC volume Volume as defined by Stop Condition Output:Remaining Countdown in minutes as defined by time of step Stop ConditionProtocol 6: Washout through the Membrane Example

In an embodiment, this protocol is to move small molecular components onthe IC side to the EC side of the membrane 116. These molecules passthrough the membrane by diffusion or ultrafiltration. These couldinclude bi-products of the cell growth. IC components retained by themembrane are not removed from the IC loop. The small molecular weightelements are washed out of the EC side by replacement fluid.

The replacement volume is specified by the number of IC volumes−ECvolumes exchanged.

The protocol includes:

1) The introduction of IC media or optionally other media to the ICside. This may be media with protein.

2) The introduction of EC media or optionally other media to the ECside. This may be media without protein.

3) The IC inlet rate as described for IC/EC washout.Q _(ECA)(number of IC Exc*V _(ICE))/(number of EC Exc*V _(ECE))4) The IC circulation rate is defined by −V_(ABO)%*Q_(ICA).V _(ABO)%=V _(ABO)*10V _(ABI) V _(ABO)V_(ABO) is from point A to bioreactor outlet F on FIG. 2 and in thisexample is 42.1 mL.V_(ABI) is from point A to bioreactor inlet E on FIG. 2 and in thisexample is 9 mL.5) The EC inlet rate is the lesser of Q₆₅ or Q_(MAX) where Q₆₅ isdefined the same as Q₁₀₀ for IC/EC washout above.6) The EC circulation rate is −CD %*Q_(ECA) as described above for IC/ECwashout.7) The outlet is EC waste.8) The rocker control is the same for IC/EC washout.9) The stop condition is the number of IC and EC exchanges which may be1 or within the range of 0.5 to 5.

The brief summary is as follows.

Protocol 6 IC/EC Washout through Membrane

Purpose of protocol: Replaces small molecule components on IC side,which pass through the membrane by either diffusion or by ultrafiltration. IC components retained by the membrane are not removed fromthe IC loop. Components on EC side are washed out by fluid replacement.The replacement volume is specified as the number of IC and EC exchangesto be performed.Calculations:

-   -   One IC exchange volume (V_(ICE)) is equal to the IC Loop Volume        plus the volume from bags to IC loop.    -   One EC exchange (V_(ECE)) is equal to the EC Loop Volume plus        the volume from bags to EC Loop.        Step 1: Washout Through Membrane

Input Range IC Source Reagent IC Media (Default) Wash EC Media EC SourceReagent IC Media Wash EC Media (Default) Stop Condition # of ICExchanges: 1 (default) range: 0.5-5.0 # of EC Exchanges: 1 (default)range: 0.5-5.0 IC Inlet Rate Value: Q_(ECA) (# of IC Exc. * V_(ICE))/(#of EC (ml/min) Exc. * V_(ECE)) IC Circulation Rate Value: −V_(ABO) % *Q_(ICA) (ml/min) EC Inlet Rate Initial value: the lesser of Q₆₅ orQ_(max); where (ml/min) Q₆₅ = 100 (# of EC Exc. * V_(ECE))/(# of ICExc. * V_(ICE)) and Q_(max) = 300. EC Circulation Rate Value: −CD % *Q_(ECA) (ml/min) Outlet EC Waste Rocker On (−90°, 180°, 1 sec) (def)Range: full range (deg, time) fixed (0°) Range: full range (deg) Output:IC volume Volume as defined by Stop Condition Output: EC volume Volumeas defined by Stop Condition Output: Remaining Countdown in minutes asdefined by Stop Condition time of stepProtocol 7: Continuous Add of IC with Ultrafiltration Example

In an embodiment, this protocol adds generally IC fluid at a low flowrate and keeps large molecules on the IC side of the fiber. A similarprotocol could be used to add fluid at low flow rate to the EC side.Excess IC fluid will be removed through ultrafiltration if the IC inletpump 254 is used.

This protocol includes:

1) The IC media is introduced through valve 250 by pump 254 with othermedia being optional alternatives.

2) EC media may optionally be added but in the IC example the EC inletflow rate is 0.

3) The IC inlet flow rate is 0.1 mL/min from a range of 0 to 10 mL/min.

4) The IC circulation rate through IC loop 202 is at a maximum ofQ_(ICCM), 10×Q_(ICA). Q_(ICCM) is the IC circulation pump rate to keepIC loop 202 well mixed without preventing air from entering filter 116.The inlet pump 254 rate Q_(ICA), plus the circulation pump 212 rateequals the Q_(ICCM) which in this example is 20 mL/min.5) The EC circulation rate is Q_(ECCM) or the pump 228 rate to keep theEC loop 204 well mixed, for example 30 mL/min.6) The outlet for the excess IC fluid is EC waste as the fluid entersthe EC loop 204 through ultrafiltration through the membrane.7) The rocker control for bioreactor 100 is fixed.8) The stop condition is a manual stop by the operator althoughalternatively the stop could be based on selected time or selected IC orEC volume.

Below is a summary of the Continuous Add with Ultrafiltration protocol.

Protocol 7 Continuous Add with Ultra Filtration

Purpose of protocol: Continuously adds fluid at a low flow rate to theIC loop and/or the EC loop. Large molecules may be concentrated in theIC loop if you use the IC Inlet pump for this task. This protocol usesultrafiltration to remove excess IC fluid if you use the IC Inlet pump.Step 1: Feed

Input Range IC Source Cell Inlet Reagent IC Media (Default) Wash ECMedia None EC Source Reagent IC Media Wash EC Media (Default) None StopCondition Time (1440 min) Range: 0.1 to 1440 minutes Manual Stop(Default) IC volume: (150 mL) Range: 1 to 4000 mL EC volume: (150 mL)Range: 1 to 4000 mL IC Inlet Rate Default: 0.1 (ml/min) Range: 0 to 10mL/min IC Circulation Rate Default: Maximum of (Q_(ICCM), 10 × Q_(ICA))(ml/min) Range: −100 to 100 mL/min EC Inlet Rate Default: 0 (ml/min)Range: 0 to 10 mL/min EC Circulation Rate Default: Q_(ECCM) (ml/min)Range: 10 to 300 mL/min Outlet EC Waste Rocker Control On (−90°, 180°, 1sec) Range: full range (deg, time) Fixed (0°) (Def) Range: full range(deg) Output: IC volume Volume or rate as defined by Stop ConditionOutput: EC volume Volume or rate as defined by Stop Condition Output:Remaining Countdown in minutes or manual stop as defined time of step byStop ConditionProtocol 8: Continuous Add with Active Removal Example

In an embodiment, this protocol uses a relatively low flow rate tocontinuously add to the IC and/or EC loops. Excess IC fluid is removedusing EC waste through the membrane 116.

The protocol includes:

1) IC media is added through valve 250 and pump 254 to the IC circuit.Alternatively, other media could be provided continuously such as cellinlet, reagent, wash solution or EC media. If the addition of media orfluid is only for the EC side, there may be no input of fluid throughthe IC side.2) Optionally or alternatively media may be added from an EC source tothe EC side if only EC addition is desired. The addition may be EC mediathrough valve 276 and pump 278. Alternatively there may be no EC inputas the addition is only to the EC side. Reagent, IC media, or washsolution could also be added to the EC side.3) On the IC side the IC inlet rate of pump 254 is 0.1 mL/min for lowflow rate addition. This is selected from a range of 0 to 10 mL/min.4) For IC addition the IC circulation rate is the maximum of Q_(ICCM) or10×Q_(ICA) with Q_(ICCM) being the rate of the IC circulation pump 212to keep the IC loop well mixed and Q_(ICA) being the rate of the inletpump 254 in mL/min selected from a range from −100 to 100 mL/min. Forexample it may be 20 mL/min.5) If the low flow addition is to the EC side the EC inlet rate may beselected to be 0.1 mL/min from a range of 0 to 20 mL/min.6) For the EC addition the EC circulation rate is selected to beQ_(ECCM) which is the rate of the circulation pump 228 in mL/minselected from a potential range of 0 to 100 mL/min, for example 30mL/min.7) The outlet in this example is EC waste.8) The rocker control for the bioreactor 100 is off with no rotation.9) The stop condition for the protocol is manually though italternatively may be based on the time (for example 0.1 to 1440 minutes)or IC or EC volumes (for example IC or EC volumes may be from 1 to 4000mL).

The brief summary of this protocol is set forth below.

Protocol 8 Continuous Add with Active Removal

Purpose of protocol: Continually adds a low flow rate to the IC and/orEC loops. A pump is used to remove excess IC fluid.

Step 1:

Input Range IC Source Cell Inlet Reagent IC Media (Default) Wash ECMedia None EC Source Reagent IC Media Wash EC Media (Default) None StopCondition Time Manual Stop (Default) IC volume: EC volume: IC Inlet RateDefault: 0.1 (ml/min) Range: 0 to 10 mL/min IC Circulation Rate Default:Maximum of (Q_(ICCM), 10 × Q_(ICA)) (ml/min) Range: −100 to 100 mL/minEC Inlet Rate Default: 0.1 (ml/min) Range: 0 to 20 mL/min EC CirculationRate Default: Q_(ECCM) (ml/min) Range: 0 to 100 mL/min Distribution RateDefault: = (—) Q_(ICA) (ml/min) Outlet EC Waste (Default) Rocker ControlOn Off (Default) fixed Output: IC volume Volume or rate as defined byStop Condition Output: EC volume Volume or rate as defined by StopCondition Output: Remaining Countdown in minutes or manual stop asdefined time of step by Stop ConditionProtocol 9: Reagent Add Example

In an embodiment, this protocol loads reagent from reagent bag 244through valve 248 by pump 254 into the IC side until the bag is empty.The IC waste valve 290 is closed for circulation through circulationloop 202. The cell inlet bag 262 includes at V_(FTO) of air which isdefined as (1+LP %/100)*V_(ICBL)+5 mL, for example 38 ml. LP % is abouta 20% pump error. V_(ICBL) is the volume from bag 244 to IC loop. Thecell inlet bag has at least 10 mL of fluid.

The protocol includes:

1) Introduction of reagent through valve 248 by pump 254 to the IC loop202.

2) Introduction of air, as pump 254 continues, from cell inlet bag 262.

3) Nothing is introduced on the EC side.

4) The IC inlet rate from pump 254 is 10 mL/min selected from a range of0 to 100 mL/min.

5) The IC circulation rate from pump 212 is the maximum of the ICcirculation pump rate 212 to keep the IC loop 202 well mixed or a valueselected from the minimum of 300 or 10×Q_(ICA) (IC inlet pump 254 rate),for example, 100 mL/min.

6) There is no EC inlet but the circulation rate is the rate of thecirculation pump 228 to keep the EC loop well mixed, for example 30mL/min.

7) The outlet is EC waste through valve 292. IC waste through valve 290is an option.

8) The rocker control for the bioreactor 100 is fixed or stationary.Alternatively, the rocker control range of motion is from −90° to 180°with 1 second pauses at the end of the motion range.

9) The stop for the reagent load is when air reaches the lower sensor1264 of the air removal chamber or ARC.

10) After air detection the ARC is filled to the upper sensor 1268 fromthe IC media or a bag such as wash solution or EC media bag that did notcontain reagent. Valve 260 and vent are open to purge ARC air.

11) Media such as IC media through valve 250 and moved by pump 254continues to chase any reagent from the ARC to the IC loop 202.

12) The stop condition for the chase of reagent is the IC volume(V_(ARCA)+V_(ARCBS))*2.

V_(ARCA) is the volume from the bottom sensor of the ARC to point A onFIG. 2 .

V_(ARCBS) is the volume of the ARC between top and bottom sensors. Forexample, the IC volume may be 22 mL. The range for this volume isbetween 0 to 100 mL.

The brief summary of this protocol is set forth below.

Protocol 9 Reagent Add

Purpose of protocol: Loads reagent from the reagent bag into the IC loopuntil the bag is empty. The IC waste valve is closed during thisprotocol.

Step 1: Load Reagent

Purpose of Step: Loads reagent into the system.

Precondition: Need at least V_(FTO) of air in cell inlet bag.

Input Range IC Source Cell Inlet Reagent (Default) EC Source None StopCondition ARC Stop IC Inlet Rate Default: 10 (ml/min) Range: 0 to 100mL/min IC Circulation Rate Default: Maximum of (Q_(ICCM), min(300,(ml/min) 10 × Q_(ICA))) Range: −300 to 300 mL/min EC Inlet Rate (ml/min)Default: 0 EC Circulation Rate Default: Q_(ECCM) (ml/min) Range: 0 to300 mL/min Outlet EC Waste (default) IC Waste Rocker Control On (−90°,180°, 1 sec) Range: full range (deg, time) Fixed (0°) (Default) Range:full range (deg) Output: IC volume rate as defined by Stop ConditionOutput: EC volume N/A Output: Remaining ARC Stop as defined by StopCondition time of stepStep 2: ARC ChasePurpose of Step: Chases reagent from the ARC into the IC Loop.

Input Range IC Source IC Media (Default) Wash EC Media Note: user cannotchoose same bag used in step 1 because that bag is now empty EC SourceNone Stop Condition IC volume: (V_(ARCA) + V_(ARCBS))*2 Range: 1 to 100mL IC Inlet Rate Default: Same as Step 1 (ml/min) IC Circulation RateDefault: Same as Step 1 (ml/min) EC Inlet Rate Default: same as Step 1(ml/min) EC Circulation Rate Same as Step 1 (ml/min) Outlet Same as step1 Rocker Same as Step 1 Output: IC volume Volume as defined by StopCondition Output: EC volume Volume as defined by Stop Condition Output:Remaining Countdown in minutes as defined by Stop Condition time of stepProtocol 10: Bolus Add Example

In an embodiment, this protocol adds a selected volume of reagent intothe IC loop. A bolus into the EC loop can also optionally be added. Ifthe IC waste (valve 290) is closed ultrafiltration through the membrane116 to the EC side will occur.

The protocol includes:

1) Reagent as the IC source is introduced through the pump 254.Alternatively other sources of media or wash could be used for a bolusamount.

2) No EC source. However, if bolus amount is to EC side only there wouldbe no IC source and bolus amount would be introduced by pump 278.

3) For IC bolus, inlet would be 10 mL/min selected from a range up tothe rate of the inlet pump.

4) The IC circulation rate is the maximum of Q_(ICCM) as compared to theminimum of 300 or 10×Q_(ICA) as described above with respect to theReagent Add protocol. This is selected from the range of −300 to 300mL/min. In this example it may be 100 mL/min.

5) If the bolus is to the EC side there is no IC inlet or source.

6) The EC circulation is Q_(ECCM) or the rate of the circulation pump228 to keep the EC loop 204 well mixed. In this example it may be 30mL/min.

7) The outlet is EC waste through valve 292. Alternatively it could beto harvest through valve 298 or to IC waste through valve 290.

8) The rocker control is off or alternatively could be set for rotationas described previously.

9) The stop condition can be selected to be based on time up to 20minutes or an IC volume selected to be 10 mL in a range up to 200 mL.

The Bolus Add protocol is summarized below.

Protocol 10 Bolus Add

Purpose of protocol: Quickly adds a selected volume of reagent into theIC loop; you can add an EC bolus at the same time. During the defaultcondition the IC waste valve closed, which forces ultrafiltration.

Step 1: Bolus Add

Input Range IC Source Reagent (Default) IC Media Wash EC Media None ECSource Reagent IC Media Wash EC Media None (Default) Stop Condition Time(1 min) Range: 0.1 to 20 min IC volume: 10 (Default) Range: 1 to 200 mLEC volume: (15 mL) Range: 1 to 300 mL IC Inlet Rate Default: 10 (ml/min)Range: 0 to Q_(ARC) mL/min IC Circulation Rate Default: Maximum of((Q_(ICCM), min(300, (ml/min) 10 × Q_(ICA))) Range: −300 to 300 mL/minEC Inlet Rate Default: 0 (ml/min) Range: 0 to 300 mL/min EC CirculationRate Default: Q_(ECCM) (ml/min) Range: 0 to 300 mL/min Outlet EC Waste(default) IC Waste Harvest Rocker On (−90°, 180°, 1 sec) Range: fullrange (deg, time) Fixed (0°) (Default) Range: full range (deg) Output:IC volume Volume as defined by Stop Condition Output: EC volume Volumeas defined by Stop Condition Output: Remaining Countdown in minutes asdefined by Stop Condition time of stepProtocol 11: Harvest Cells Example

In an embodiment, the protocol relates to transferring cells once theyare in suspension from the IC loop. Additional protocols described belowrelate to releasing the cells from the membrane 116 in the bioreactor toplace them in suspension prior to harvest.

The protocol includes as follows:

1) Media is inputted from an IC source such as IC media through valve250 and pump 254. Alternatively reagent, wash solution or EC media couldbe the IC source. The media may be harvest media. As the cells arenon-adherent and have been reloaded from the membrane, no tryspin isrecirculated after release from the membrane.2) Similarly EC media is provided through valve 276 and pump 278. Washsolution, reagent or IC media could also be introduced.3) The IC inlet rate is 400 mL/min selected from a range from 100 to 500mL.4) The IC circulation rate is −AB %*Q_(ICA) with AB % isV_(AB)*100/V_(ICL). V_(AB) is the volume from point A to point B on FIG.2 and V_(ICL), is the volume of the IC loop 202. Q_(ICA) is the pumprate of the inlet pump 254. In this example it is 69 mL/min.5) The EC inlet rate is UFR₄₀₀ or the negative ultrafiltration raterequired to have zero transmembrane pressure at the bioreactor outlet inco-current flow and IC inlet rate=400 mL/min and EC waste valve 292 isclosed. The upper range is 100 mL/min and in this example it is 60mL/min.6) The EC circulation rate is Q_(ECCM) as described previously in arange up to 300 mL/min, for example 30 mL/min.7) The outlet for the suspended cells is the harvest bag which receivesthe IC outlet.8) The rocker control for bioreactor rotation is from −90° to 180° with1 second pauses at the end position.9) The stop condition for the protocol is IC volume 2×V_(ICL), forexample 378 mL.

The brief summary of the Harvest Cell protocol is as follows.

Protocol 11 Harvest Cells

Purpose of protocol: Transfers cells in suspension from the IC loop,including cells in the bioreactor, to the harvest bag.

Step 1: Harvest Cells

Purpose of Step: Same as above

Input Range IC Source Reagent IC Media (Default) Wash EC Media EC SourceReagent IC Media Wash EC Media (Default) Stop Condition IC volume: 2 ×V_(ICL) (Default) Range: 50 to 1000 mL IC Inlet Rate Default: 400(ml/min) Range: 100 to 500 mL/min IC Circulation Rate Value= −AB % *Q_(ICA) (ml/min) Range: −AB % * Q_(ICA) Minimum to −AB % * Q_(ICA)Maximum Note: Q_(ICA) Minimum and Q_(ICA) Maximum values refer to the ICInlet Rate (ml/min) Range. EC Inlet Rate Default: UFR₄₀₀ (ml/min) Range:0 to 100 mL/min EC Circulation Rate Default: Q_(ECCM) (ml/min) Range: 0to 300 mL/min Outlet Harvest Rocker Control On (−90°, 180°, 1 sec.)(def) Range: full range (deg, time) Output: IC volume Volume Output: ECvolume N/A Output: Remaining Countdown in minutes or manual stop asdefined time of step by Stop ConditionProtocol 12: Release Adherent Cells Example

In an embodiment, this protocol may be executed and followed prior tothe Harvest Cell protocol.

The first part of the protocol may include a change of IC/EC media. Forexample, a media such as PBS may be used to remove protein, calcium ormagnesium form the suspension.

The second part of the protocol relates to the addition of a reagentsuch as trypsin to release the cells from the membrane 116. This isfollowed by a chase to the IC loop as well as mixing the reagent in theIC loop.

The protocol includes as follows:

1) Addition of wash solution through valve 270, 212 and pump 254 to ICside. Reagent solution, EC media or IC media are optional alternativesif they contain a solution such as PBS. In this example, 1370 mL of PBSwas used.

2) If the cells are on the EC side the alternative would be for ECintroduction of PBS.

3) The IC inlet rate is

Q_(ECA) (number of IC Exc*V_(ICE)/(number of EC Exc*V_(ECE)). V_(ICE) isthe IC exchange volume V_(ICL)+V_(ICBL). V_(ECE) is the EC exchangevolume V_(ECL)+V_(ECBL).

4) The IC circulation rate is −AB %*Q_(ICA) as described in thedefinitions which in this example is −17 mL/min.

5) The EC inlet rate is the lesser of Q₁₀₀ or Q_(MAX) where Q₁₀₀=100(number of EC Exc*V_(ECE)) (number of IC Exc.*V_(ICE)) and Q_(MAX)=300.In this example the EC inlet rate is 148 mL/min.

6) The EC circulation rate is −CD %*Q_(ECA) as defined in thedefinitions.

7) The outlet can be IC waste or EC waste or both through valves 290 or292.

8) The rocker control for bioreactor 100 is −90°, 180° with 1 secondpause at the end of the range of motion, or alternatively fixed.

9) The stop condition for the wash is the number of IC and EC exchanges,in this example 2.5 each.

10) The wash is followed by the reagent introduction such as tryspin torelease the cells. This is from the reagent bag 244 through valve 248and pump 254. At least a volume V_(FTO) is needed in the bag.

11) The IC inlet is 50 mL/min.

12) The IC circulation is 300 mL/min.

13) There is no EC inlet but circulation is Q_(ECCM) or rate to keep ECloop mixed.

14) The rocker control is on as described above with chase.

15) The stop condition is the ARC stop or when the lower sensor 1264detects air.

16) After air detection the ARC is filled with wash or alternatively ICor EC media to upper sensor 1268.

17) Mixing of the reagent continues in the IC loop for 4 minutes.

The protocol summary is as set forth below.

Protocol Release Adherent Cells

Purpose of protocol: Releases cells from the membrane, leaving the cellsin the IC Loop.

Step 1:

Purpose of Step: Performs Protocol IC/EC Washout in preparation foradding reagent. For example, the system replaces IC/EC media with PBS toremove protein, Ca⁺⁺, and Mg⁺⁺ in preparation for adding trypsin.

Input Range IC Source Reagent IC Media Wash (Default) EC Media EC SourceReagent IC Media Wash (Default) EC Media Stop Condition # of ICExchanges: 2.5 (default) range: 0.5-5.0 # of EC Exchanges: 2.5 (default)range: 0.5-5.0 IC Inlet Rate Value: Q_(ECA) (# of IC Exc. * V_(ICE))/(#of (ml/min) EC Exc. * V_(ECE)) IC Circulation Rate Value: −AB % *Q_(ICA) (ml/min) EC Inlet Rate Initial value: the lesser of Q₁₀₀ orQ_(max); where (ml/min) Q₁₀₀ = 100 (# of EC Exc. * V_(ECE))/(# of ICExc. * V_(ICE)) and Q_(max) = 300. EC Circulation Rate Value: −CD % *Q_(ECA) (ml/min) Outlet IC Waste EC Waste IC&EC Waste (default) RockerOn (−90°, 180°, 1 sec) (def) Range: full range (deg, time) Fixed (0°)Range: full range (deg) Output: IC volume Volume as defined by StopCondition Output: EC volume Volume as defined by Stop Condition Output:Remaining Countdown in minutes as defined by Stop Condition time of stepParameters to be tested:

-   -   Check for any updates from Protocol IC/EC Washout.        Step 2: Load Reagent        Purpose of Step: Loads reagent into the system until the bag is        empty.        Precondition: Need at least V_(FTO) of air in bag containing the        reagent.

Input Range IC Source Cell Inlet Reagent (Default) EC Source None StopCondition ARC Stop IC Inlet Rate Default: 50 (ml/min) Range: 20 to 100mL/min IC Circulation Rate Default: 300 (ml/min) Range: 30 to 300 mL/minEC Inlet Rate Default: 0 (ml/min) EC Circulation Rate Default: Q_(ECCM)(ml/min) Range: 0 to 300 mL/min Outlet EC Waste Rocker Control On (−90°,180°, 1 sec) (def) Range: full range (deg, time) Output: IC volumeVolume as defined by Stop Condition Output: EC volume N/A Output:Remaining ARC Stop as defined by Stop Condition time of stepStep 3: ARC ChasePurpose of Step: Chases the reagent into the IC Loop.

Input Range IC Source IC Media Wash (Default) EC Media EC Source NoneStop Condition IC volume: (V_(ARCA) + V_(ARCBS))*2 Range: 1 to 100 mL ICInlet Rate Default: Same as Step 2 (ml/min) IC Circulation Rate Default:Same as Step 2 (ml/min) EC Inlet Rate Default: 0 (ml/min) EC CirculationRate Default: Same as Step 2 (ml/min) Outlet EC Waste Rocker ControlSame as Step 2 Output: IC volume Volume as defined by Stop ConditionOutput: EC volume N/A Output: Remaining Countdown in minutes as definedby Stop Condition time of stepStep 4: MixPurpose of Step: Mixes the reagent within the IC Loop.

Input Range IC Source None EC Source None Stop Condition Time: 4 minutes(default) Range: 0.1 to 20 minutes IC Inlet Rate Default: 0 (ml/min) ICCirculation Rate Same as step 2 (default) (ml/min) Range: 30 to 300mL/min EC Inlet Rate Default: 0 (ml/min) EC Circulation Rate Same asstep 2 (default) (ml/min) Range: 0 to 300 mL/min Outlet EC Waste RockerControl Same as step 2 Output: IC volume N/A Output: EC volume N/AOutput: Remaining Countdown in minutes as defined by Stop Condition timeof stepProtocol 13: Condition Media

In an embodiment, this protocol oxygenates the EC media before theaddition of cells to the IC side of the bioreactor 100. The initialsteps of the protocol include:

1) The EC source is generally EC media without protein introducedthrough valve 276 by pump 278.

2) IC circulation is enough to prevent air introduction through thehollow fibers or Q_(ICCM). In this example, it is 20 mL/min.

3) The EC inlet rate is 0.1 mL/min.

4) The EC circulation rate is Q_(ECCE) or the pump rate to equilibratethe EC loop. In this example it is 25 mL/min.

5) The outlet is EC waste through valve 292.

6) The rocker control is fixed with no rotation.

7) The stop for the high circulation rate conditioning is based on timefrom a range of 6 to 15 minutes.

8) A maintenance protocol is part of the condition media protocol.

9) The conditions for maintenance are the same as that outlined above,except that the EC circulation is reduced to Q_(ECCM) which is the rateof the circulation pump to keep the EC loop mixed, for example 30mL/min. Also, the stop for maintenance is a manual operator controlledstop. The maintenance is maintained until the operator desires cellload.

The summary of the protocol is as follows.

Protocol Condition Media

Purpose of protocol: Oxygenates the media to proper concentrationsbefore loading the cells.

Step 1:

Purpose of Step: Accelerates the conditioning of the media using a highEC circulation rate.

Input Range IC Source None EC Source Reagent IC Media Wash EC Media(Default) Stop Condition Time: T_(CM) Range: 6 to 15 minutes IC InletRate Default: 0 (ml/min) IC Circulation Rate Default: Q_(ICCE) (ml/min)EC Inlet Rate Default: 0.1 (ml/min) EC Circulation Rate Default:Q_(ECCE) (ml/min) Outlet EC Waste Rocker Fixed (0°) Range: full range(deg) Output: IC volume N/A Output: EC volume N/A Output: RemainingCountdown in minutes time of stepStep 2: CirculatePurpose of Step: Maintains the system in a proper state until theoperator is ready to load the cells.

Input Range IC Source None EC Source Same as step 1 Stop ConditionManual Stop IC Inlet Rate Default: 0 (ml/min) IC Circulation Rate Sameas step 1 (ml/min) EC Inlet Rate Same as step 1 (ml/min) EC CirculationRate Default: Q_(ECCM) (ml/min) Range: 0 to 100 mL/min Outlet EC WasteRocker Control Fixed (0°) Range: full range (deg) Output: IC volume Rateas defined by stop condition Output: EC volume Rate as defined by stopcondition Output: Remaining manual stop as defined by stop conditiontime of stepProtocol 14: Coating Bioreactor Example

In an embodiment, this protocol is directed to coating the IC side ofthe bioreactor with a reagent such as fibrenectin for cell attachment.Other reagents can be used. The protocol loads the reagent until thereagent bag is emptied, chases the reagent from the ARC, and circulatesthe reagent. In the protocol, the cell inlet bag contains V_(FTO) or(1+LP %/100*V_(ICBL)+5 mL) as described in the definitions, according toembodiments. In this example, it is 40.2 mL.

The protocol includes:

1) Providing reagent from reagent bag through valve 248 and pump 254 tothe IC side.

2) Cell inlet bag also may be open for fluid flow through valve 264.

3) There is no EC source or inlet rate.

4) The IC inlet rate is 10 mL/min.

5) The IC circulation rate is the maximum of (20, (min (300,10×Q_(ICA))) with Q_(ICA) being the inlet pump 254 rate. In thisexample, it is 100 mL/min.

6) EC circulation rate is Q_(ECCM) as described previously as thecirculation rate to keep to EC loop mixed. In this example, it is 30mL/min.

7) The outlet is EC waste through valve 292.

8) The rocker control is off. Alternatively it could rotate from −90° to180° with 1 second pauses at the end of the range of motion.

9) The stop condition for the reagent load is detection of air by lowersensor 1264 of the ARC.

10) After reagent load stop the ARC is loaded to upper sensor 1268 andgas evacuates through outlet 1224 and valve 260.

11) The chase can be IC media, wash or EC media provided through valve270 if wash solution and pump 254 to the IC side.

12) The stop condition for the chase portion of the protocol is ICvolume (V_(ARCA)+V_(ARCBS))*2. V_(ARCA) is the volume from the bottom ofthe ARC to point A on FIG. 2 . V_(ARCBS) is the volume of the ARCbetween sensors.

13) For circulation of the reagent, a low flow EC media is provided onthe EC side. This may be media through valve 276 or from the reagent, ICmedia or wash bags through pump 278.

14) The EC inlet rate during circulation is 0.1 mL/min.

15) The IC inlet rate is Q_(ICCM) which is the circulation pump 212 rateto keep the IC loop well mixed.

16) The EC circulation rate is Q_(ECCM) which is the EC circulation pump228 to keep the EC loop well mixed, in this example 30 mL/min.

17) The stop condition for circulation is either time selected or amanual stop.

The protocol is summarized below.

Protocol Coat Bioreactor

Purpose of Task: Coats the bioreactor membrane with a reagent.

Step 1: Load Reagent

Purpose of Step: Loads reagent into the system.

Precondition: Need at least V_(FTO) of air in the cell inlet bag.

Input Range IC Source Cell Inlet Reagent (Default) EC Source None StopCondition ARC Stop IC Inlet Rate Default: 10 mL/min (ml/min) Range: 0.1to 100 mL/min IC Circulation Rate Default: Maximum of (20, (min(300, 10× (ml/min) Q_(ICA))) Range; −300 to 300 mL/min EC Inlet Rate Default: 0(ml/min) EC Circulation Rate Default: Q_(ECCM) (ml/min) Range: 0 to 100mL/min Outlet EC Waste Rocker Control On (−90°, 180°, 1 sec) Range: fullrange (deg, time) Fixed (0°) (Default) Range: full range (deg) Output:IC volume Volume or Rate as defined by stop condition Output: EC volumeVolume or Rate as defined by stop condition Output: Remaining Countdownin minutes or manual stop as defined by time of step stop conditionStep 2: ARC ChasePurpose of Step: Chases reagent from the ARC into the IC Loop.

Input Range IC Source IC Media Wash (Default) EC Media EC Source NoneStop Condition IC volume: (V_(ARCA) + V_(ARCBS))*2 Range: 1 to 100 mL ICInlet Rate Default: Same as Step 1 (ml/min) IC Circulation Rate Default:Same as Step 1 (ml/min) EC Inlet Rate Default: 0 (ml/min) EC CirculationRate Default: Same as Step 1 (ml/min) Outlet EC Waste Rocker ControlSame as Step 1 Output: IC volume Volume as defined by stop conditionOutput: EC volume n/a Output: Remaining Countdown in minutes or manualstop as defined by time of step stop conditionStep 3: CirculatePurpose of Step: Circulates reagent in the IC Loop.

Input Range IC Source None EC Source Reagent IC Media Wash (Default) ECMedia Stop Condition Time (1 min) Range: 0.1 to 2880 minutes Manual Stop(default) IC Inlet Rate Default: 0 (ml/min) IC Circulation Rate Default:Q_(ICCM) (ml/min) EC Inlet Rate Default: 0.1 (ml/min) EC CirculationRate Default: Q_(ECCM) (ml/min) Outlet EC Waste Rocker Control Same asStep 1 Output: IC volume n/a Output: EC volume Rate as defined by stopcondition Output: Remaining Manual stop as defined by stop conditiontime of stepProtocol 15: Cell Attachment Example

In an embodiment, the purpose of this protocol is to enable adherentcells to adhere to the IC side of the membrane while allowing flow onthe EC side. The cells are already in the IC side.

The protocol includes as follows:

1) Only an EC source and EC circulation is used. There is no IC source,IC inlet rate or IC circulation rate.

2) The EC inlet is EC media with options for reagent, IC media, or wash.The media flows though valve 276 as EC media, and through pump 278.

3) The EC inlet rate is low 0.1 mL/min flow.

4) The EC circulation rate Q_(ECCM) as described above which in thisexample is 30 mL/min.

5) The outlet is the EC waste through valve 290.

6) The rocker control is fixed or stationary.

7) The stop condition is a manual stop. Alternatively the stop could bebased on time or EC volume.

The brief summary of the protocol is as shown below.

Protocol Cell Attachment

Purpose of protocol: Enables adherent cells to attach to the membranewhile allowing flow on the EC loop. The pump flow rate to the IC loopflow is set to zero.

Step 1: Cell Attachment

Input Range IC Source None EC Source Reagent IC Media Wash EC Media(Default) Stop Condition Time: (1440 min) Range: 0.1 to 2880 minutesManual Stop (Default) EC volume: (150 mL) Range: 1 to 4000 mL IC InletRate Default: 0 (ml/min) IC Circulation Rate Default: 0 (ml/min) ECInlet Rate Default: 0.1 (ml/min) Range: 0.1 to 10 mL/min EC CirculationRate Default: Q_(ECCM) (ml/min) Range: 0 to 100 mL/min Outlet EC WasteRocker Control Fixed (0°) (Default) Range: 0° to 180° Output: IC volumeVolume or rate as defined by Stop Condition Output: EC volume Volume orrate as defined by Stop Condition Output: Remaining Countdown in minutesor manual stop as defined by time of step Stop ConditionProtocol 16: User-Defined Task Example

In an embodiment, this protocol allows the user to define the task. Thesetting options are as follows:

Setting Setting Options IC Inlet Cell Reagent IC Media Wash EC MediaNone IC Inlet Rate 0 to 500 mL/min IC Circulation Rate −300 to 300mL/min EC Inlet Reagent IC Media Wash EC Media None EC Circulation Rate−300 to 300 mL/min Outlet EC Waste IC Waste Synchronization RockerControl In Motion (−180° to 270°, 0 to 15 seconds) Stationary (−180° to270°) Stop Condition Manual Time (0.1 to 1440 min) IC Volume (1 to 4000mL) EC volume (1 to 4000 mL)

Having described various protocols for use with the cell expansionsystem, embodiments further relate to processor-implemented methods andsystems for configuring and customizing protocols, and other settings,of the cell expansion system, through the use of UIs and GUI elements.For example, a user or operator, may select a UI element or GUI element,such as a button or other control, associated with a particular setting,including a system setting, display setting, and/or protocol setting.Such selection may be made, according to embodiments, by touching alocation on a touch screen or other display area of a display device.Settings associated with the selected GUI element may then be configuredthrough the input of data, for example. In embodiments, suchconfigurations are stored.

The system provides for further user customizations by allowing a useror operator to create one or more custom or user-defined tasks and toadd steps to the custom tasks, in accordance with embodiments of thepresent disclosure. For example, such added steps may be selected from alist of pre-defined processes, including Wash Out Lines, Wash Out LinesThrough Membrane, Wash Rapidly, Harvest Cells, Add Bolus, and Custom, inwhich the Custom step provides for an added step to be a custom stepitself, according to embodiments. Steps may also be omitted from a task,and configured settings may be reset to the factory default settings,according to other embodiments, through the selection of an applicableGUI element.

The configurability and customization capabilities of the cell expansionsystem allow the system to be adapted to a user or operator's desiredsettings and preferences, according to embodiments of the presentdisclosure. Through the use of UIs, GUI elements, and process diagramviews or windows for configuring and customizing settings and systemcomponents, the system provides a visual tool for the configuration andcustomization of the system. Such capabilities provide an efficient wayto configure and customize the system and protocols used therewith.

Turning to FIG. 7 , an example logical environment 700 for interactingwith a UI of a cell expansion system is shown in accordance withembodiments disclosed herein. A cell expansion system 702 housing afluid conveyance device accessed by opening the door of the cellexpansion system with handle 704 is shown according to an embodiment.The cell expansion system 702 is capable of being interacted with by auser or operator 708, for example. The cell expansion system 702comprises a UI 706 for displaying, and allowing interaction with,information and data related to the cell expansion system 702. Inembodiments of the present disclosure, a UI, such as UI 706, forexample, may be any interface for providing information to a user oroperator 708 or for receiving input from a user or operator 708. A ULsuch as UI 706, for example, may include application windows, renderedby a processor, such as the processor discussed with reference to FIG.24 below, for an application, such as a configuration and/orcustomization application, according to embodiments.

UI 706 provides, in embodiments, for interaction by a user or operator708, for example, with the cell expansion system 702 through the use ofinput devices, output devices, logical modules, e.g., software, andhardware, e.g., physical elements. UI 706 allows the user or operator708 to operate and control the cell expansion system 702 and to view, orotherwise receive, the result(s) of such operation and control,according to embodiments herein. Such operation and control may include,for example, configuring and/or customizing settings of the cellexpansion system, including protocols for use with the system. Asdiscussed with respect to FIG. 24 below, the cell expansion system 702,including UI 706, is driven by a processor, memory, etc.

Logical environment 700 is not limited to any particular implementationbut, rather, encompasses any environment upon which the functionality ofenvironment 700 may be practiced. For example, user or operator 708 maybe a single user or operator or multiple users or operators. Further, inother embodiments, cell expansion system 702 may be interacted with byanother device, program, machine, etc. Logical environment 700represents an example way of practicing embodiments disclosed herein butis not intended to limit the scope of the present disclosure. Forexample, logical environment 700 may be considered with respect to thespecific components present, e.g., processor, or may be considered withrespect to the corresponding modules.

While FIG. 7 shows example environment 700 for operating, configuring,and/or customizing the cell expansion system according to embodiments,FIG. 8 illustrates an example UI 800 comprising GUI elements for makingconfiguration selections in accordance with further embodiments of thepresent disclosure. UI 800 is displayed on the user interface 706 of thecell expansion system 702, for example. UI 800 may be retrieved inresponse to a user selecting to configure the cell expansion system, inwhich a screen entitled, “Configuration Selection” 802 with configureicon 803, appears to allow the user to make configuration selections.The screen name, “Configuration Selection” 802, and configure icon 803are offered as an example for purposes of illustration. Numerous typesof titles, names, headings, and/or icons may be used in accordance withembodiments without departing from the spirit and scope of the presentdisclosure. As shown in UI 800, GUI elements 804, 806, 808, and 810allow a selection to be made to configure an aspect of the cellexpansion system, such as of cell expansion system 702 shown in FIG. 7 .For example, a selection may be made to configure display settings 804,system settings 806, default settings for tasks or protocols 808, and/orany other type of configuration aspect 810 related to the cell expansionsystem 702, according to embodiments. GUI elements shown in FIG. 8 mayinclude, for example, buttons, controls, icons, boxes, radio buttons,checkboxes, menus, drop-down menus, windows, including pop-up windows,etc. In embodiments, UI 800 provides a status bar 812 includinginformation related to the system, including the date and time andstatus of the system performance, such as “Idle.” Further, alarm 816,rocker control 818, other controls (as shown by ellipsis 820), and dooricon 822 (for indicating when the door of cell expansion system 702 isopen, for example) also provide information regarding the cell expansionsystem, according to embodiments. Further, in an embodiment, temperaturewindow 824 displays relevant temperatures, including, for example, theactual temperature of the air inside the incubator and the temperatureset point. In addition, pressure window 826 provides the currentpressure measurements at the IC and EC inlets and outlets, as well asthe inlet and outlet differential pressures, according to an embodiment.Other GUI elements include a “Task” GUI element 828 for displaying thetask selection screen, a “Configuration” GUI element 830 for displayinganother configuration screen, and an “About” configuration GUI element832 for displaying information regarding the cell expansion system,including, for example, identification information for the device,version information, etc., according to embodiments. In addition, othertypes of GUI elements may be included to assist a user to navigate thesystem and UIs, as shown by ellipsis 834 and the “Other” GUI element836. Further, the “Configuration Selection” screen may be closed withselection of the “Close” GUI element 814.

While FIG. 8 provides configuration selection options, FIG. 9Aillustrates an example UI 900 for configuring display settings of thecell expansion system, in accordance with embodiments of the presentdisclosure. For example, UI 900 provides for changing the format of thedate display, changing the format of the time display, setting thecurrent date and time, selecting a language for the display of text, andselecting a decimal separator type. The screen name “Configuration:Display” 902 and icon 904 indicate that the UI provides for configuringdisplay settings. Any type of screen name and configuration icons may beused in accordance with embodiments herein. The screen name 902 and icon904 are offered for purposes of illustration. UI 900 allows forconfiguration of the date 906, time 922, local preferences 948, andother 962 display settings as shown by ellipsis 960. UI 900 allows auser, for example, to select the date format 908, such as whether thedate used with display settings for the system includes a “MM-DD-YYYY”910 format, a “DD-MM-YYYY” 912 format, or a “YYYY-MM-DD” 914 format, inwhich “M” refers to “month,” “D” refers to “day” of the month, and “Y”refers to “year.” The hatching at button 910 indicates that button 910has been selected, such as by touching this button using the touchscreen of the cell expansion system, according to embodiments. The useof hatching in the Figures herein is offered for purposes ofillustration only. Any type of visual indicia may be used withoutdeparting from the spirit and scope of the present disclosure. Further,a user may select to enter the current date 916, including the month904, day 918, and year 920.

In addition, UI 900 allows for a selection of the time format 924, inwhich a user, for example, may select a 12 hour format 926 or a 24 hourformat 928. The current time 930 may also be entered using UI 900 byproviding data for the hour 932, minute 934, and second 946 fields.

Turning to FIG. 9B, for example, a user has selected to enter thecurrent date for the display settings of the system, in which an arrowat 904 indicates a selection of the current date. In response toreceiving the selection to configure the date, the system determinesthat a numeric value is associated with the current date setting. Inresponse to such determination, the system provides a data entry pad 976to allow for the input of one or more numeric values for entering thecurrent date, according to embodiments. After providing numeric valuesthrough the use of the data entry pad or data entry window 976, UI 900,as shown in FIG. 9C, displays the filled-in current date 904, 918, and920.

In addition, a selection may be made to provide or modify the currenttime 930, in which a data entry window or data entry pad or other meansmay also be provided for receiving entry of numeric values for theassociated time fields 932, 934, and 946. FIG. 9C shows the results ofthe system receiving numeric values for the time fields 932, 934, and946. Further, in embodiments where a 12-hour clock is used, a selectionmay be made, or data may be provided, for example, to designate whetherthe indicated time is for the “a.m.” (ante meridiem) period or for the“p.m.” (post meridiem) period.

Returning to FIG. 9A, UI 900 also provides for a configuration of “LocalPreferences” 948, in which a selection may be made as to whether numericvalues use a “period” 952 or “comma” 954 decimal separator 950. Further,the language 956 used for displaying the text used in displaying dataand information using the display area of UI 706 may also be selected,according to embodiments. For example, while “English” 958 is shown asthe default language, GUI element 958 may be selected, as shown by the“arrow” pointer on the “English” 958 GUI element of FIG. 9D.

In response to receiving the selection, the system determines that amenu, list, or window of selection options should be provided in UI 900,as shown in FIG. 9D, according to embodiments of the present disclosure.In an embodiment, such selection options are dynamically determined. Inanother embodiment, such selection options are predetermined orpre-defined. The language selection window 978 displays various GUIelements for different language options. The languages listed in menu978 are offered for purposes of illustration only. Any number and/ortype of languages may be offered depending on the system characteristicsin accordance with embodiments disclosed herein. Further, the languagechoices may be displayed in any language without departing from thespirit and scope of the present disclosure. While the language selectionwindow 978 of FIG. 9D shows the options using English text, otherembodiments provide for the language choices to each be written in theirrespective languages.

Returning to FIG. 9A, UI 900 provides for the configurations to be saved966 and stored by the system, according to an embodiment, in which thesystem stores and applies the configured changes. In such an embodiment,the configuration screen then closes. In another embodiment, a selectionmay be made to “Cancel” the configuration of display settings byselecting the “Cancel” button 964, in which the Configuration: Displaywindow closes and returns to another screen, for example. Further, UI900 provides a status bar 968 including information related to thesystem, including the date and time and status of the systemperformance, such as “Idle.” Further, alarm 970, rocker control 972,other controls (as shown by ellipsis 974), and door icon 976 (forindicating when the door of cell expansion system 702 is open, forexample) also provide information regarding the cell expansion system,according to embodiments.

While FIGS. 9A, 9B, 9C, and 9D illustrate UI 900 for configuring displaysettings, FIGS. 10A and 10B depict UI 1000 for configuring systemsettings, in accordance with embodiments of the present disclosure. Forexample, UI 1000 provides for turning the incubator on or off, changingthe temperature set point of the system, turning the alarm sound on oroff, setting the low-temperature alarm for the system, etc. The screenname “Configuration: System” 1002 and icon 1003 indicate that the HIprovides for configuring system settings. Any type of screen name andconfiguration icons may be used in accordance with embodiments herein.The screen name 1002 and configure icon 1003 are offered for purposes ofillustration. In configuring system settings, a selection may be made toturn the incubator 1004 “on” 1006 or “off” 1005. The temperature setpoint 1008 of the system may also be set 1010 by selecting GUI element1010, in which the temperature set point is the point at which thetemperature of the system incubator is set, according to an embodiment.In an embodiment, a default temperature set point is provided. However,this numeric value may be configured by selecting, or touching in anembodiment using a touch screen, the temperature set point field 1010.For example, an “arrow” pointer is shown as selecting the temperatureset point field 1010 in FIG. 10B. As shown in UI 1000 of FIG. 10B, thesystem, in response to receiving the selection of the temperature setpoint field 1010, determines that a numeric value is associated with thetemperature set point field 1010. After determining that a numeric valueis associated with field 1010, the system provides a data entry windowor data entry pad 1042 for receiving an input of data for the desiredtemperature set point. After receiving such data, the system updates thetemperature set point field 1010, in accordance with embodimentsdisclosed herein.

Returning to FIG. 10A, the low-temperature alarm 1012 may be configuredby turning it “on” 1014 or “off” 1013. In an embodiment, the alarm isshown as being turned “off” 1013 in FIG. 10A through the use ofhatching. This selection (and others shown) are offered for purposes ofillustration only. The difference from the set point 1016 may also beset by selecting field 1018. In response to receiving the selection ofthe difference from set point field 1018, the system determines that anumeric value is associated with the field 1018. After determining thata numeric value is associated with field 1018, the system provides adata entry window or data entry pad such as shown in FIG. 10B at dataentry pad 1042, for example, for receiving an input of data for thedesired difference from set point. After receiving such data, the systemupdates the difference from set point field 1018, in accordance withembodiments disclosed herein. Next, as shown in FIG. 10A, the systemalarm sound 1020 may be turned “on” 1022 or “off” 1024 by selecting theappropriate button for such desired configuration. The selected buttonchanges color to “black” or another designated color or visual indiciato show selection, according to embodiments. The “on” button 1022 isshown as being selected in FIG. 10A. Any type of visual indicia changemay be used in accordance with embodiments of the present disclosurewithout departing from the spirit and scope of the present disclosure.Further, other system settings 1028 may be configured as shown byellipsis 1026.

After making desired configurations, such changes may be saved byselecting the “Save” button 1030, in which the system responds to suchselection by saving and applying the changes. The configuration screenthen closes, according to embodiments. In another embodiment, aselection may be made to “Cancel” 1032 the configuration of displaysettings by selecting the “Cancel” button 1032, in which theConfiguration: System window closes and returns to another screen.Further, UI 1000 provides a status bar 1005 including informationrelated to the system, including the date and time and status of thesystem performance, such as “Idle.” Further, alarm 1034, rocker control1036, other controls (as shown by ellipsis 1038), and door icon 1040(for indicating when the door of cell expansion system 702 is open, forexample) also provide information regarding the cell expansion system,according to embodiments.

Turning to FIG. 11 , UI 1100 provides for configuring a task or protocolfor use with the cell expansion system, in accordance with embodimentsof the present disclosure. As shown, UI 1100 appears with screen name“Configure Confirmation: Task A,” for example, after the system receivesa selection to configure a system task or protocol. In embodiments,“Task A” refers to a predetermined or pre-defined task, such as “ReleaseAdherent Cells with Harvest,” for example. Such selection may beinitially made as shown by selecting button 808 in FIG. 8 and thenselecting a particular type of predetermined or pre-defined protocol,such as “Release and Harvest,” and then selecting “Release AdherentCells with Harvest,” according to an embodiment. In another embodiment,UI 1100 appears after an initial configuration of a task or protocol ismade, and the system is providing a confirmation of the desiredconfiguration. Other embodiments provide for selecting the configurationof protocols through other buttons or GUI elements, for example. Thescreen name, “Configure Confirmation: Task A” 1102 is offered as anexample for purposes of illustration. Numerous types of titles, names,headings, and/or icons may be used in accordance with embodiments of thepresent disclosure without departing from the spirit and scope of thepresent disclosure.

UI 1100 allows for the configuring of default settings for each task orprotocol. When the default settings for a particular task or protocol,e.g., a first task, are configured, the system replaces the factorydefault settings for the task, e.g., the first task, with the settingsthat are configured. In embodiments, the system also stores the newlyconfigured settings. In embodiments, each time a task, e.g., first task,is subsequently selected, the system automatically populates thesettings for the first task with the configured default settings.Embodiments also allow the default settings to be reset, or restored,back to the factory default settings by selection of the “Reset” buttonor GUI element 1156 of FIG. 11 . Selecting “Reset” 1156 restores all ofthe settings for a selected task back to the factory default settingsfor that task, according to embodiments. In embodiments, the restorationof the factory default settings is stored upon selection of the “Save”GUI element 1158.

Further, UI 1100 of FIG. 11 shows the number of steps 1112 included inthe particular task or protocol listed 1102. For example, UI 1100 shows“step 1” 1114, “step 2” 1116, and other steps 1120, as shown by ellipsis1118. Any number of steps, or a single step, may be included accordingto embodiments of the present disclosure. Further, other steps not shownin UI 1100 may be included, as shown by the ability to use buttons orother controls 1104, 1106, 1110, and 1111 for moving between screensdisplaying other steps, in embodiments. Ellipsis 1108 represents otherbuttons or controls which may be used for moving between screens inaccordance with embodiments of the present disclosure. While not shownin FIG. 11 , the title of a particular step may be displayed by the stepnumber. For example, for the “Release Adherent Cells with Harvest”protocol, “step 1” 1114 may list “Wash Out Lines,” “step 2” 1116 maylist “Load Reagent,” and “step 3” 1120 may list “Chase ARC,” accordingto an embodiment of the present disclosure.

Further, one or more settings for a particular step may be configured byselecting the appropriate “Configure” GUI element, such as configurebutton 1148 for step 1, configure button 1150 for step 2, configurebutton 1154 for another step 1120, or any other number of configurebuttons as shown by ellipsis 1152 for associated steps shown by ellipsis1118. Such settings to configure include, for example, IC Inlet 1122, ICInlet Rate 1124, IC Inlet Rate 1126, EC Inlet 1128, EC Inlet Rate 1130,EC Circulation Rate 1132, Outlet 1134, Rocker 1136, Stop Condition 1138,Estimated Fluid Needed 1140, Omit or Include Step 1142, and othersettings 1146 as shown by ellipsis 1144, according to embodiments of thepresent disclosure. In embodiments, the “Omit or Include Step” 1142indicates whether a particular step is included or omitted from thetask. While sample data and selected options, e.g., “Wash” or “Reagent,”are shown in FIG. 11 for particular settings, in which such data andselected options may represent factory default settings according toembodiments, these data and selected options are shown for purposes ofillustration. The data and selected options shown in FIG. 11 areexamples only.

After making desired configurations, such changes may be saved byselecting the “Save” button 1158, in which the system responds to suchselection by saving and applying the changes. The configuration screenthen closes, according to embodiments. In an embodiment, theconfiguration screen 1100 shows the changes applied to the settings(after any configurations are made) when configuration screen 1100appears in response to another later selection to configure the protocolor task, for example. In yet another embodiment, changes applied to thesettings are shown after the configuration screen closes byautomatically displaying an updated UI 1100 following the saving andclosing of the configuration screen. In another embodiment, a selectionmay be made to “Cancel” 1160 the configuration of display settings byselecting the “Cancel” button 1160, in which the Configure Confirmation:Task A window closes and returns to another screen. Further, UI 1100provides a status bar 1162 including information related to the system,including the date and time and status of the system performance, suchas “Idle.” Further, alarm 1164, rocker control 1166, other controls (asshown by ellipsis 1168), and door icon 1170 (for indicating when thedoor of cell expansion system 702 is open, for example) also provideinformation regarding the cell expansion system, according toembodiments.

While FIG. 11 illustrates example UI 1100 for configuring a task orprotocol, with associated processes or steps, for a predetermined orpre-defined task, FIGS. 12A, 12B, and 12C depict example UI 1200 forconfiguring a custom or user-defined task, in accordance withembodiments of the present disclosure. A custom or user-defined task maybe created according to embodiments. The system provides, inembodiments, for multiple custom or user-defined tasks, such as Custom1, Custom 2, Custom 3, Custom 4, Custom 5, etc. In an embodiment, acustom or user-defined task allows a user or operator to enter all ofthe settings for a task manually. The factory default settings andsetting options for a step, e.g., a first step, of a custom oruser-defined task comprise the following, according to an embodiment:

Setting Factory Default Setting Options IC Inlet None Cell, Reagent, ICMedia, Wash, EC Media, None IC Inlet Rate 0 mL/min 0 to 500 mL/min ICCirculation Rate 0 mL/min −300 to 300 mL/min EC Inlet None Reagent, ICMedia, Wash, EC Media, None EC Inlet Rate 0 mL/min 0 to 300 mL/min ECCirculation Rate 0 mL/min −300 to 300 mL/min Outlet EC Waste EC Waste,IC Waste, Synchronization Rocker Control Stationary (0°) In Motion (−180to 270°, 0 to 15 sec), Stationary (−180 to 270°) Stop Condition ManualManual, Time (0.1 to 1440 min), IC Volume (1 to 4000 mL), EC Volume (1to 4000 mL)

Upon receiving the factory default settings, a user may manually enterdata and/or make selections from selection options for a particularsetting(s). In an embodiment, such selection options are provided in theform of a menu, list, window, etc. In a further embodiment, suchselection options are predetermined or pre-defined. Further, a step ormultiple steps may be added to a custom or user-defined task, in whichthe settings of each step may be modified. The system provides for auser to select a type of step to add, in which such steps include, inembodiments: Wash Out Lines, Wash Out Lines Through Membrane, WashRapidly, Harvest Cells, Add Bolus, and Custom. Factory default settingsprovided for each selected step may then be used or modified, accordingto embodiments. The system, in embodiments, does not save the manuallyentered settings but, instead, provides for the settings to be enteredeach time the particular custom task is performed.

In other embodiments, the settings for a custom or user-defined task,such as for Custom 1, may be configured. Configured settings may besaved, and such settings may then be used when the particular configuredcustom task is subsequently selected or executed, for example. As shownin FIG. 12A, a custom task, such as custom task 1, may be configured. UT1200 may be retrieved in response to a user selecting to configure acustom task of the cell expansion system, in which a screen entitled,“Configure Confirmation: Custom Task 1” 1202 appears to allow the userto make configurations. The screen name, “Configure Confirmation: CustomTask 1” 1202 is offered as an example for purposes of illustration.Numerous types of titles, names, and/or headings may be used inaccordance with embodiments of the present disclosure without departingfrom the spirit and scope of the present disclosure. UI 1200 appearswith screen name “Configure Confirmation: Custom Task 1,” for example,after the system receives a selection to configure a system task orprotocol. Such selection may be initially made as shown by selectingbutton 808 in FIG. 8 , then selecting “Custom,” and then selecting theCustom Task desired, such as “Custom Task 1.” The Configure Confirmationscreen then appears for the selected custom task. In another embodiment,UI 1200 appears after an initial configuration to a custom oruser-defined task or protocol is made, and the system is providing aconfirmation of the desired configuration. Other embodiments provide forselecting the configuration of protocols, including custom protocols,through other buttons or GUI elements, for example.

As shown in FIG. 12A, UI 1200 lists the number of steps 1212 in thecustom or user-defined task and displays the step(s), as shown by custom“step 1” 1214 in UI 1200. Where other steps are included, such steps mayappear in the Configure Confirmation window UI 1200, or in otherembodiments, such steps may be viewed by using the buttons or controls1204, 1206, 1210, and 1211 to move between screens. Ellipsis 1208represents other buttons or controls which may be used for movingbetween screens in accordance with embodiments of the presentdisclosure. By selecting “configure” button 1248, settings associatedwith “step 1” 1214 of custom task 1 may be configured. Such settings toconfigure include, for example, IC Inlet 1222, IC Inlet Rate 1224, ICInlet Rate 1226, EC Inlet 1228, EC Inlet Rate 1230, EC Circulation Rate1232, Outlet 1234, Rocker 1236, Stop Condition 1238, Estimated FluidNeeded 1240, and other settings 1246 as shown by ellipsis 1242,according to embodiments of the present disclosure. While sample dataand selected options, e.g., “EC Waste,” are shown in FIG. 12A forparticular settings, in which such data and selected options mayrepresent factory default settings according to embodiments, these dataand selected options are shown for purposes of illustration only. Thedata and selected options are examples only.

Embodiments also allow for the default settings to be reset, orrestored, back to the factory default settings by selection of the“Reset” button or GUI element 1256 of FIG. 12A. Selecting “Reset” 1256restores all of the settings for a selected custom task back to thefactory default settings for the custom or user-defined task, accordingto embodiments. Any configurations made may be saved and stored by thesystem by selecting the “Save” button 1252, according to an embodiment,in which the system stores and applies the configured changes. In suchan embodiment, the configuration screen then closes. In anotherembodiment, a selection may be made to “Cancel” the configuration ofdisplay settings by selecting the “Cancel” button 1254, in which theConfigure Confirmation window closes and returns to another screen.Further, UI 1200 provides a status bar 1258 including informationrelated to the system, including the date and time and status of thesystem performance, such as “Idle.” Further, alarm 1260, rocker control1262, other controls (as shown by ellipsis 1264), and door icon 1266(for indicating when the door of cell expansion system 702 is open, forexample) also provide information regarding the cell expansion system,according to embodiments.

According to embodiments, a step may be added to Custom Task 1, forexample, by selecting the button, “Add Step” 1268. In response toreceiving a selection of add step GUI element 1268, the system providesa window or menu 1269 of options for the added step type, as shown in UI1200 of FIG. 12B. For example, a selection may be made from thefollowing options: Wash Out Lines 1270, Wash Out Lines Through Membrane1272, Wash Rapidly 1274, Harvest Cells 1276, Add Bolus 1278, Custom1280, and other step 1282. Further, a selection may be made to “Cancel”1284 the addition of a step by selecting the Cancel button 1284, inwhich the selection menu or window 1269 closes. While options 1270,1272, 1274, 1276, 1278, 1280, 1282, and 1284 are depicted in selectionwindow 1269, any types of GUI element types may be used withoutdeparting from the spirit and scope of the present disclosure. Theoptions presented in window 1269 are offered for purposes ofillustration. Following a selection of a step from window 1269, FIG. 12Cshows an updated UI 1200, including added custom “step 2” 1286 and datafor settings 1222, 1224, 1226, 1228, 1230, 1232, 1234, 1236, 1238, 1240,and 1246. Further, the added step, shown as custom “step 2” 1286, may beconfigured through selection of the configure button 1288. Further,other step(s) may be added through selection of the “add step” button1268, according to embodiments. The settings shown in FIGS. 12A, 12B,and 12C are shown in a table view. Other types of views may be used inaccordance with embodiments of the present disclosure. The table view ofUI 1200 is shown for purposes of illustration.

After selecting to configure a step or process of a task or protocol, adiagram view of the cell expansion system is provided as shown with UI1300 in FIG. 13A, according to embodiments of the present disclosure.The diagram view 1300 depicts the cell expansion system, including theintracapillary (IC) and extracapillary (EC) sides of the bioreactor1305, according to embodiments. Arrows, or other icons, in UI 1300 showthe bi-directional flow between the IC and EC sides of the bioreactor.The diagram view 1300 may include designated colors or other visualindicia representing the various sides of the bioreactor, according toembodiments. Further, GUI elements, such as buttons, are associated withvarious settings. In embodiments, visual indicia, and changes thereof,may be used to show selections of the GUI elements associated withvarious settings, in which the settings include, according toembodiments: IC Inlet 1304, IC Inlet Rate 1306, IC Circulation Rate1308, Outlet IC and EC Waste 1316, EC Circulation Rate 1314, EC InletRate 1312, and EC Inlet 1310. In further embodiments, changes in visualindicia may be used to show those settings capable of being modified orconfigured. In embodiments, settings may be configured only for settingsthat are available for the selected task. If a setting cannot beconfigured, the button, or other GUI element, associated with thesetting is not enabled, in accordance with embodiments. For example, theGUI elements 1304, 1306, and 1308 associated with settings IC Inlet, ICInlet Rate, and IC Circulation Rate, respectively, are shown as enabledin UI 1300. Embodiments also provide for changes in visual indicia toshow the status of a task when the system is performing the task, forexample.

As noted, UI 1300 appears with screen name “Configure Defaults: Task A”1302 upon selection of a step to configure. As shown in FIG. 13A, acustom or user-defined task, such as custom task 1, may be configuredthrough the use of the diagram view depicted in UT 1300. The diagramview depicted in UI 1300 may also be referred to as a configure defaultsscreen, according to an embodiment. UI 1300 further includes textindicating the step or process being configured 1304, in which theexample shown in UI 1300 indicates that the “Wash Out Lines: Step 1/5”1304 is being configured. Text 1304 is offered for purposes ofillustration. Any other steps or text may be used in accordance withembodiments of the present disclosure. While the diagram view depictsthe cell expansion system in UI 1300, a tabular view of the setting datamay also be selected with icon 1303, according to embodiments. Further,UI 1300 provides for the rocker setting 1318 to be configured, in whichthe rocker setting determines the position and movement of thebioreactor during a step or process. In an embodiment, the rockersetting 1318 may be designated as stationary. In another embodiment, therocker setting 1318 may be designated as in motion, in which the rangeof degrees of motion determines the clockwise or counter-clockwisemovement direction of the bioreactor 1305. Further, the rocker includesa dwell time setting which indicates the amount of time the system restsat the start and end positions. Rocker GUI element 1318 may be selectedto set any of these settings 1320, according to embodiments. Further,stop condition GUI element 1322 provides for determining how and whenthe cell expansion system stops the performance of a current task orstep of a task. For example, the stop condition setting options include,according to embodiments: manual, time, IC volume, EC volume, exchange,and empty air removal chamber (ARC). As shown in FIG. 13A, UI 1300 has astop condition 1322 of Exchange 1324, for example.

Diagram view 1300 of FIG. 13A further illustrates buttons to include1326 or omit 1328 the step depicted, according to embodiments. A user oroperator may also desire to configure a previous step 1330 or a nextstep 1332 and move to the configuration screens for these respectivesteps by selecting previous step button 1330 or next step button 1332,respectively. After making desired configurations to the setting orsettings of the noted step, the “confirm” GUI element 1334 may beselected to confirm the configurations and close the diagram view of UI1300. UI 1300 provides a status bar 1336 including information relatedto the system, including the date and time and status of the systemperformance, such as “Idle.” Further, alarm 1338, rocker control 1340,other controls (as shown by ellipsis 1342), and door icon 1344 (forindicating when the door of cell expansion system 702 is open, forexample) also provide information regarding the cell expansion system,according to embodiments.

In the embodiment shown in FIG. 13A, the GUI element associated with theIC Inlet Rate setting 1306 is selected, as shown by the arrow, orpointer, at GUI element 1306 in UI 1300. In response to selection of GUIelement 1306, the system determines that the IC Inlet Rate is associatedwith a numeric value and provides a data entry window 1346 or data entrypad 1346 in the diagram view 1300 depicted in FIG. 13B. As shown in FIG.13B, GUI element 1306 is depicted as selected, as shown by the change ofa visual indicator, e.g., a first indicator, associated with GUI element1306 in FIG. 13B as compared to a visual indicator, e.g., a secondindicator, associated with GUI element 1306 in FIG. 13A. After providingdata using data entry window 1346, GUI element 1306 is updated toreflect the received data, according to embodiments.

In another embodiment, GUI element 1304 is selected, as shown by thechange of a visual indicator, e.g., second indicator, associated withGUI element 1304 of UI 1300 in FIG. 13C as compared to a visualindicator, e.g., first indicator, associated with GUI element 1304 inFIG. 13A. Upon receiving the selection of GUI element 1304 forconfiguration, the system determines that GUI element 1304 is associatedwith the IC Inlet and that a selection option is applicable to the ICInlet. The system then retrieves the applicable selection options forthe IC Inlet and presents the options in window or menu 1348. Forexample, window or menu 1348 provides selection options for the IC Inletof: IC Media 1350, Reagent 1352, Cell 1354, EC Media 1356, Wash 1358, orNone 1360. Further, the window or menu 1348 provides for a user oroperator to cancel the selection of a setting type for GUI element 1304by selecting the “Cancel” button 1362 in menu or window 1348. In anembodiment, the GUI element 1304 depicted in the diagram view of UI 1300is then updated with the selection made with window or menu 1348. In anembodiment, the IC Inlet is shown as depicting a “Wash” for the tasklisted of “Wash Out Lines” 1304. However, these settings and task type,as noted, are offered for purposes of illustration only.

While FIGS. 13A, 13B, and 13C show the selections of particular GUIelements, these selections are offered for purposes of illustration. Anytypes of selections may be made in embodiments. In addition, diagramview 1300 may include additional data, controls, and/or other GUIelements, including a pressure window, temperature window, systemwindow, etc. (not shown), according to embodiments. Diagram view 1300may also include fewer GUI elements, data, etc., according to otherembodiments.

With respect to FIGS. 8, 9A, 9B, 9C, 9D, 10A, 10B, 11, 12A, 12B, 12C,13A, 13B, and 13C above, while a single UI associated with each screenmay be provided according to embodiments of the present disclosure,multiple Ills can be displayed in accordance with other embodimentsdisclosed herein. Ills 800, 900, 1000, 1100, 1200, and 1300 are offeredfor purposes of illustration. Any type of UIs and GUI elements can beused in accordance with embodiments of the present disclosure. Inanother embodiment, a UI is not used. Rather, a configuration selection,input data, and output data may be provided by another device, output,etc., in accordance with embodiments of the present disclosure.

While various example UIs for interacting with a user or operator, forexample, of the cell expansion system have been described, FIGS. 14A,14B, 14C, and 14D illustrate example operational steps 1400 formodifying a predetermined or pre-defined task type, in accordance withembodiments of the present disclosure. Start operation 1402 is initiatedby opening a home screen, for example, of the cell expansion system, andprocess 1400 proceeds to receive selection of a task operation 1404, inwhich a button or other GUI element for selecting a task or protocol isselected. In embodiments, a home screen of the cell expansion systemcomprises GUI elements to allow a selection of a desired action, such asa selection to execute a task, a selection to configure a setting, etc.The system then provides a choice of task types, including pre-definedor predetermined tasks 1406, such as load tasks, wash tasks, add tasks,and harvest tasks, according to embodiments. Further embodiments providefor the task types to be further described, in which specific task namesare provided for the task types, including the following:

-   -   Load tasks: High flux load, load with circulation, coat        bioreactor, cell attachment    -   Wash: Bone marrow washout, aggressive washout, IC EC washout, IC        EC washout through membrane, wash inlet line    -   Add: Continuous add with ultrafiltration, reagent add, bolus        add, continuous add    -   Harvest: Harvest cells, release adherent cells, release with        harvest.

The type of task selected is then received 1408, and the defaultsettings for the selected task type are retrieved 1410. Setting optionsfor the task type are also retrieved 1412. Process 1400 then continuesvia off-page reference A 1414 to operation 1415 of FIG. 14B, in whichthe default settings are provided in table form in a setup confirmationview screen. Next, it is determined 1416 whether an indication isreceived to modify the settings for a process or step, in which a“Modify” button or other GUI element may be selected in the setupconfirmation view screen. If an indication to modify a setting is notreceived, process 1400 proceeds NO to query 1418 to determine if anindication to execute the task is received. In an embodiment, anindication to execute the task comprises selecting a “Start” button orother UI element indicating to run the task. If an indication to executethe task is received, the system executes or performs the task 1420.Process 1400 then terminates at END operation 1422. If query 1418determines that an indication to run the protocol is not received,process 1400 proceeds to receive another indication 1424, such as anindication to exit the setup screen, for example. Other indications maybe received in other embodiments. The system then responds to thereceived indication 1426, and process 1400 then terminates at ENDoperation 1422.

Returning to query 1416, if it is determined that an indication isreceived to modify a setting, process 1416 proceeds YES to determine thestep selected to modify 1428. The settings associated with the selectedstep are then retrieved 1430. The retrieved setting(s) are associatedwith GUI element(s) 1431. For example, the system associates 1431 asetting, e.g., a first setting, with a GUI element, e.g., a first GUIelement. The GUI element may be further associated with data associatedwith the setting, e.g., default data, according to embodiments. Forexample, a GUI element may be associated with a numeric value, a mediatype, e.g., Cells, Reagent, etc., depending on the associated settingtype. In embodiments, the first GUI element displayed in the diagramwindow shows the default data associated with the first GUI element.

Query 1432 then determines if specific settings are available formodification, e.g., a determination is made as to whether specificsettings can be modified, in which the settings capable of beingmodified are identified by the system. In response to determining thatall settings associated with the selected step can be modified, process1400 proceeds “All” to enable for selection all GUI element(s)associated with the setting(s) 1436. On the other hand, in response todetermining that only specific settings are available for modification,process 1400 branches “Specific” at query 1434 to enable specific GUIelements for selection 1434. A diagram view or window showing theenabled and/or non-enabled settings is then provided, in which suchproviding includes: rendering the GUI element(s) 1437 and displaying thediagram view or window with the enabled and/or non-enabled GUIelement(s) 1438. Process 1400 then continues through off-page referenceB 1440 to operation 1442 of FIG. 14C, in which an indication to modify aselected setting is received by selection of a GUI element associatedwith the desired setting in the diagram view, according to an embodimentof the present disclosure. Information for the selected setting is thenretrieved 1444.

Next, the system determines at query 1446 whether the selected settingis associated with a numeric value. For example, a rate, such as the ICInlet Rate, is associated with a numeric value. If it is determined 1446that the selected setting is associated with a numeric value, process1400 branches YES to provide data entry pad 1448. An entry of data isreceived 1450. It is then determined whether the entry is within therange of setting options 1452. If the entry is within the range ofsetting options, process 1400 proceeds YES to update the selectedsetting 1454. Process 1400 then continues through off-page reference C1468 to query 1470. If the entry is not within the range of settingoptions, process 1400 proceeds NO to receive another data entry 1450,and process 1400 then continues to operation 1452. In an embodiment,query 1452 is optional, and process 1400 proceeds directly to update thesetting 1454 according to the received value.

Returning to query 1446, if the selected setting is not associated witha numeric value, process 1400 proceeds NO to query 1456 to determinewhether a menu or window of options is applicable to the selectedsetting. If a menu or window of options is applicable to the selectedsetting, process 1400 proceeds YES to retrieve applicable options 1458.The menu or window of options is then provided 1460, and a selection isreceived 1462. The selected setting is then updated 1454, and process1400 proceeds through off-page reference C 1468 to query 1470. Returningto query 1456, if a menu or window of options 1456 is not applicable tothe selected setting, process 1400 proceeds NO to provide otherinput/selection capability, such as a field, button, control, etc.,1464. A selection is then received 1466, and the selected setting isupdated 1454. Process 1400 then proceeds through off-page reference 1468to query 1470 of FIG. 14D.

Next, query 1470 determines whether a confirmation of the settingsprovided is received. If a confirmation is not received, query 1470proceeds NO to receive a selection to modify another setting or settings1472 from within the diagram view. Process 1400 then proceeds throughoff-page reference D 1474 to FIG. 14C, and process 1400 then continuesat operation 1442. If query 1470 determines that the modified settingsare confirmed, process 1400 proceeds YES to provide an updated setupconfirmation view, such as in table form, for example, 1476. It is nextdetermined 1478 whether an indication is received to modify any othersteps 1478 from within the setup confirmation view. If it is desired tomodify other steps, process 1400 proceeds YES to off-page reference E1480, and process 1400 then continues to FIG. 14B where the selectedstep for modification is determined 1428. If it is determined at query1478 not to modify other steps, process 1400 proceeds NO to determinewhether an indication is received to execute the task 1482. If aselection to run the task is received, process 1400 proceeds YES toexecute task operation 1484, in which the protocol is performed with thecell expansion system. Process 1400 then terminates at END operation1486. If an indication is not received to execute the task 1482, process1400 proceeds NO to query 1496 to determine whether an indication isreceived to reset the modified setting(s) to the factory defaultsettings. If an indication to “Reset” is received, such as by selectinga GUI element associated with the “Reset” functionality, process 1400proceeds YES to reset the settings to the default values 1498. In anembodiment, the default values comprise the factory default values. Ifan indication to reset is not received, process 1400 proceeds NO toquery 1490 to determine whether an indication to cancel the setup forthe selected protocol is received. If an indication to cancel isreceived, process 1400 proceeds YES to exit the setup confirmation view1491. Process 1400 then terminates at END operation 1492. If anindication to cancel is not received 1490, process 1400 proceeds NO toreceive another indication 1493, such as an indication to move toanother screen, for example. The system then responds 1494 to theindication, and process 1400 terminates at END operation 1492.

While FIGS. 14A, 14B, 14C, and 14D relate to modifying a setting(s) of astep of a protocol or task, FIGS. 15A and 15B illustrate exampleoperational steps 1500 for configuring settings of the cell expansionsystem, in which such settings are stored and replace the applicabledefault settings, in accordance with embodiments of the presentdisclosure. Start operation 1502 is initiated, and process 1500 proceedsto receive a selection to configure a setting 1504, in which a“Configuration” GUI element related to configuration aspects for thesystem, such as a GUI element displayed on the system home screen, isreceived. In response to receiving the selection to configure 1504, thesystem provides configuration options 1506, including options toconfigure the display settings, system settings, and/or task defaultsettings. Next, it is determined 1508 which of system settings, displaysettings, or task default settings is selected for configuration. If thesystem settings are selected 1510, process 1500 proceeds to retrievesystem setting options 1510, and the system setting options forconfiguration, such as alarm sound, incubator “on” or “off,” etc., areprovided 1512, according to embodiments. Process 1500 then continuesthrough off-page reference A 1514 to operation 1541 of FIG. 15B. If itis desired to configure display settings, process 1500 proceeds toretrieve the display setting options 1516, and the display settingoptions are provided 1518, in which such display setting configurationoptions include date and time format, etc., according to embodiments.

Alternatively, if the default settings for tasks is selected, process1500 proceeds to provide the task types 1520, including pre-defined orpredetermined tasks and custom tasks, according to an embodiment. Aselection of the task type desired is received 1522, and it isdetermined 1524 which selection has been made, i.e., custom orpre-defined or predetermined task. If a predetermined or pre-definedtask selection is received, process 1500 branches “Pre-Defined” toproviding a list of the pre-defined task options 1526, receiving aselection of a predetermined task option 1528, retrieving defaultsettings 1530 for the selected task, and providing the default settingsfor the selected predetermined task 1532. Process 1500 then continuesthrough off-page reference A 1514 to operation 1541 of FIG. 15B.Returning to query 1524, if a custom or user-defined task selection isreceived, process 1500 branches “Custom” to listing custom oruser-defined task options, such as Custom Task 1, Custom Task 2, etc.,1534. A selection of a custom task option, e.g., Custom Task 1, isreceived 1536. Default settings for the custom task are retrieved 1538,and the default settings for the custom task are provided 1540. Process1500 then proceeds through off-page reference A 1514 to operation 1541of FIG. 15B.

At operation 1541 of FIG. 15B, a selection of a particular step orprocess of the task to configure is received, in accordance withembodiments of the present disclosure. In embodiments, the system thenprovides a diagram view 1542 of the cell expansion system for the stepselected. A selection of a GUI element associated with a setting toconfigure is then received 1543, and it is determined whether theselected setting is associated with a numeric value, selection window ormenu, or other input capability using a window or other control 1544. Ifthe selected setting is associated with a data entry window, selectionwindow or menu, or other input/selection capability using a window orother control, process 1500 proceeds YES to provide the applicablecapability 1546, such as a data entry pad according to embodiments.Process 1500 then proceeds to operation 1548. If query 1544 determinesthat a selection of data may be received, such as in a field of the GUIelement, for example, without providing a data entry window, selectionwindow, or other input/selection capability using a window or othercontrol, process 1500 proceeds NO to receive the data or selection 1548.To store the configuration settings, an indication to “Save” is received1550, in which the system then stores the configurations 1552 andreplaces 1553 the default settings or previously configured settings1553 with the newly configured settings. In an embodiment, the firstsettings are replaced with the second configured settings 1553. Process1500 then terminates at END operation 1554.

Next, FIG. 16 illustrates example operational steps 1600 for configuringprotocol or task settings, and executing the task or protocol with theconfigured settings, according to an embodiment of the presentdisclosure. Start operation 1602 is initiated, and process 1600 proceedsto receive an indication to configure a task setting(s) 1604. A processview, or diagram view, depicting the cell expansion system, includingthe IC and EC sides of the bioreactor and related settings as associatedwith GUI elements, for example, is displayed 1606. An indication of asetting to configure is then received 1608, and a data entry pad or dataentry window, menu, or other input/selection capability is provided 1610as determined by the system as meeting the particular selected setting'scharacteristics. Information or data for the selected setting is thenreceived 1612, and, in response to receiving an indication to save thesetting configuration 1614, the system stores the configuration 1616.Next, a selection is received to execute the configured task associatedwith the configured task setting 1618. In an embodiment, an indicationto execute the task comprises selecting a “Start” button or other UIelement indicating to run the task. The configured, and stored, settingsfor the selected task are retrieved, and the task is executed with thestored setting(s) 1620. Process 1600 then terminates at END operation1622.

While FIG. 16 depicts process steps for executing a task with storedconfigurations, FIG. 17 illustrates example operational steps 1700 forinterpreting selections made using the touch screen of a user interfaceof the cell expansion system, according to embodiments of the presentdisclosure. The touch screen of the cell expansion system allows a useror operator, for example, to communicate with and interact with the cellexpansion system by selecting GUI elements, selecting options from menusor windows, entering data, etc. Start operation 1702 is initiated, suchas by turning the cell expansion system “on” or displaying a home screenfor the cell expansion system using a display device, according toembodiments. Process 1700 then proceeds to receive a touch event on thedisplay area 1704, in which a user or operator touches, or uses a touchinput device, for example, a GUI element on the display area of the cellexpansion system, such as of cell expansion system 702 of FIG. 7 . Alocation of the touch event 1706 is next determined, and the location ismapped to a UI element 1708. The system next determines that thelocation corresponds to a selection of a task configuration 1710,according to an embodiment. Data specific to the selected taskconfiguration is then retrieved 1712, such as data associated withcertain steps and/or settings of the selected task. A UI for theselected task is then rendered 1714, in which settings available forconfiguration are enabled. Information, such as a diagram view showingthe IC and EC sides of the bioreactor with relevant settings, is thendisplayed for receiving configurations 1716. A touch event is thenreceived for a setting, such as for setting “A,” for example 1718. Toshow that setting “A” has been selected for configuration, the UI isrendered with the GUI element associated with setting A having a changein visual indicia 1720 in the diagram view, for example, to show it hasbeen selected.

In an embodiment, a GUI element associated with setting A may be enabledbefore it is selected, in which the display of setting A in the diagramview shows the GUI element associated with setting A as being selectablethrough the use of a designated visual indicia. For example, the GUIelement associated with an enabled setting may be rendered and displayedas having a first color, while a GUI element associated with anon-enabled setting may be rendered and displayed as having a secondcolor. Where an enabled GUI element is selected, an additional change invisual indicia may apply. For example, an enabled GUI element forselected setting A is changed in color to a third color, for example, toshow it is selected, e.g., such as by changing it to the color “black”when it is selected. A GUI element having a change in visual indicia toshow it has been selected is displayed 1722. Input for setting A is thenreceived 1724, such as through use of a window, selection menu, or otherinput/selection mechanism, according to embodiments. The input receivedis then processed 1726. The visual indicia for setting A is thenreturned 1728 to its original visual indicia, according to embodiments.For example, the visual indicia is changed from a first indicia to asecond indicia when it is selected. Setting A is then returned to thefirst visual indicia after the requested configuration of setting A ismade. The input provided for the configuring of setting A is thendisplayed 1730, such as within the GUI element for setting A in thediagram view and/or in the table of settings for configuration, inaccordance with embodiments disclosed herein. Process 1700 thenterminates at END operation 1732.

Turning to FIGS. 18A, 18B, 18C, and 18D, example operational steps 1800are provided for configuring a pre-defined task or protocol for use withthe cell expansion system and storing the configured settings, inaccordance with embodiments. Start operation 1802 is initiated, andprocess 1800 proceeds to receiving a selection to configure 1804.Configuration selection options, including GUI elements to select toconfigure system settings, display settings, task settings, etc., areretrieved and provided 1806. A selection to configure the defaultsettings for tasks is then received 1808. The types of tasks forselection are then provided 1810, and a selection of a pre-defined taskis received 1812. The default settings for the selected task are thenretrieved 1814, and process 1800 continues through off-page reference A1816 to operation 1817 of FIG. 18B. At operation 1817, default settingsfor the selected task are provided in a configure confirmation UI, suchas shown with UI 1100 of FIG. 11 , for example. In an embodiment, theconfigure confirmation window or view includes a listing of the settingsand associated data for one or more steps associated with the selectedtask. In an embodiment, the settings and associated data are provided ina table format. Query 1818 next determines whether an indication isreceived to configure the settings for a step or process associated withthe selected task and displayed in the configure confirmation UI. If aselection to configure the settings for a step is not received, process1800 proceeds NO to query 1820, in which it is determined whether aselection to cancel the configuration is received. If an indication tocancel is received, process 1800 proceeds YES to close the configurationwindow 1822 and exit. Process 1800 then terminates at END operation1824, in which a home screen of the cell expansion system may appear,according to embodiments. If an indication to cancel is not received atquery 1820, process 1800 proceeds NO to receive another indication 1826,such as to switch to another screen through a selection of a next screenbutton, control, or icon, for example. The indication received isresponded to 1828, and process 1800 then terminates at END operation1824.

Returning to query 1818, if an indication to configure settings for astep is received, process 1800 proceeds YES to determine the stepselected 1830, and the setting(s) associated with the selected step areretrieved 1831. The retrieved setting(s) are associated with GUIelement(s) 1832. For example, the system associates 1832 a setting,e.g., a first setting, with a GUI element, e.g., a first GUI element.The GUI element may be further associated with data associated with thesetting, e.g., default data, according to embodiments. For example, aGUI element may be associated with a numeric value, a media type, e.g.,Cells, Reagent, etc., depending on the associated setting type. Inembodiments, a first GUI element displayed in the diagram view shows thedefault data associated with the first GUI element. Further, a secondGUI element displayed in the diagram view shows the default dataassociated with the second GUI element, etc.

Query 1834 next determines if specific settings are available forconfiguration, e.g., a determination is made as to whether specificsettings are configurable, in which the configurable settings areidentified by the system. As discussed above, settings may be configuredonly for settings that are available for configuration for the selectedtask, according to embodiments of the present disclosure. If a settingcannot be configured, the button, or other GUI element, associated withthe setting is not enabled for selection, in accordance withembodiments. For example, enabling the first GUI element for selectionincludes showing that the GUI element is capable of selection by the useof a visual indicator(s) showing such selection capabilities. Forexample, in embodiments, a GUI element that is not enabled is a firstcolor, while a GUI element that is enabled is a second color. A visualindicia change comprising a color change is offered for purposes ofillustration. Numerous types of visual indicia changes may be used todesignate a GUI element as being enabled without departing from thespirit and scope of the present disclosure. For example, text may beused to show whether a GUI element is enabled or not enabled, such as bylabels designating “Enabled” or “Not Enabled,” respectively. Furtherembodiments also include using any type of indicia change withoutdeparting from the spirit and scope of the present disclosure, in whichsuch indicia changes are not limited to visual indicia changes.

Returning to query 1834, in response to determining that all settingsassociated with the selected step are configurable, process 1800proceeds “All” to enable for selection all GUI element(s) associatedwith the setting(s) 1838. On the other hand, in response to determiningthat only specific settings are available for configuration, process1800 branches “Specific” at query 1834 to enable specific GUI elementsfor selection 1836. A diagram view or window showing the enabled and/ornon-enabled settings is then provided, in which such providing includes:rendering the GUI element(s) 1837 and displaying the diagram view orwindow with the enabled and/or non-enabled GUI element(s) 1840. Process1800 then proceeds through off-page reference B 1842 to operation 1844of FIG. 18C.

At operation 1844, an indication to configure a selected setting isreceived, such as by receiving a selection of a GUI element associatedwith the selected setting. Information related to the selected settingis then retrieved 1846, including information such as whether thesetting is associated with a numeric value, for example. Query 1848determines whether the setting is associated with entry of a numericvalue. If entry of a numeric value is associated with the setting,process 1800 proceeds YES to provide data entry pad or window 1850 forreceiving an entry of data 1852. In an embodiment, it may be determinedwhether the numeric value entered is within the available settingoptions 1854, for example. If the entry is not within the acceptablerange, process 1800 proceeds to operation 1852 to receive another dataentry. If the entry is within the available range 1854, process 1800proceeds YES to update the setting 1856 according to the received value.In an embodiment, query 1854 is optional, and process 1800 proceedsdirectly to update the setting 1856 according to the received value.

In an embodiment, where a value for a first configured setting isreceived, another setting may be automatically calculated by the systembased on the received first value. In an embodiment, a task may includea pump rate, such as the IC Circulation Rate, that the systemautomatically calculates based on another pump rate for the task, suchas the IC Inlet Rate. In an embodiment, a user or operator may overridean automatically calculated pump rate. In another embodiment, a user oroperator may not be permitted to override the automatically calculatedpump rate. In embodiments, setting options indicate whether it ispossible to override an automatically calculated value. As shown in FIG.18C, after updating a setting 1856 based on receiving an entry of data,for example, the system determines whether to automatically calculateany other settings in query 1870. Where no automatic calculation occurs,process 1800 proceeds NO to off-page reference C 1872, and process 1800continues to query 1873 of FIG. 18D. Where another setting isautomatically calculated based on configuration of the first setting,process 1800 proceeds YES to calculate the value for the second setting1874 and update the second setting 1876. Process 1800 then proceedsthrough off-page reference C 1872 to query 1873 of FIG. 18D. Inembodiments, query 1870 is optional, in which process 1800 provides forupdating the setting operation 1856 and proceeding through off-pagereference C 1872 to query 1873 of FIG. 18D.

Returning to query 1848, if it is determined that the selected settingis not associated with a numeric value, process 1800 proceeds NO toquery 1858 to determine if a menu, list, or window, for example, ofselection options is associated with the selected setting. In anembodiment, such selection options are predetermined or pre-defined. Inan embodiment, such selection options comprise text, such as “Wash.” Inanother embodiment, the selection options include a numeric value. If awindow or menu of selection options is associated with the selectedsetting, process 1800 proceeds YES to retrieve the applicable options1860. The menu or window of options is then provided 1862, and aselection of an option is received 1864. For example, “Wash” is selected1864 from a menu of options 1862 for the IC Inlet setting, according toan embodiment of the present disclosure. The selected setting is thenupdated 1856. Process 1800 then proceeds to query 1870 to determine ifany other settings are automatically calculated based on the selectionreceived at operation 1864. Where no other settings are automaticallycalculated based on the received selection at operation 1864, process1800 proceeds NO through off-page reference C 1872 to query 1873 of FIG.18D. In embodiments, query 1870 is optional, in which process 1800provides for updating the setting operation 1856 and proceeding throughoff-page reference C 1872 to query 1873 of FIG. 18D.

Next, returning to query 1858, where a menu or window of selectionoptions is not associated with the selected setting, process 1800proceeds to operation 1866 for providing another input/selectioncapability, such as a field, radio button, control, checkbox, etc.,according to embodiments of the present disclosure. Input is received atoperation 1868, and the selected setting is updated 1856. Process 1800then proceeds to query 1870. Where no other settings are automaticallycalculated based on the received selection at operation 1864, process1800 proceeds NO through off-page reference C 1872 to query 1873 of FIG.18D. In embodiments, query 1870 is optional, in which process 1800provides for updating the setting operation 1856 and proceeding throughoff-page reference C 1872 to query 1873 of FIG. 18D.

At query 1873 of FIG. 18D, it is determined whether a confirmation ofthe configured setting(s) is received. If no confirmation is received,process 1800 proceeds NO to determine whether a selection to include oromit a step is received 1874. If such a selection is received, theappropriate application of the request occurs 1876, and process 1800then proceeds to query 1873. If no steps are included or omitted atquery 1874, process 1800 proceeds NO to query 1878 for determiningwhether a selection to configure other settings 1878 is received. Ifother settings are desired to be configured, process 1800 proceeds YESto off-page reference D 1880, in which process 1800 continues tooperation 1844 of FIG. 18C. If no selection is received to configureanother setting(s), process 1800 proceeds NO to receive an indication toconfigure another step(s) of the selected task 1882, such as byselecting a button(s) with the applicable functionality, for example.Process 1800 then proceeds through off-page reference E 1884 tooperation 1830 of FIG. 18B. Returning to query 1873, if a confirmationof the configuration is received, process 1800 proceeds YES to providean updated configure confirmation view 1886, in which the settings,including any configured settings, are provided in the updated view1886. In an embodiment, the configure confirmation view comprises atable format. Query 1888 next determines whether an indication isreceived in the table view of the settings to configure any otherstep(s). If a selection for configuring other step(s) is received,process 1800 proceeds YES through off-page reference E 1884 to operation1830 of FIG. 18B. If no other configuration of steps is desired, process1800 proceeds NO to query 1889 to determine whether the configurationsare to be stored. If an indication to save the configuration(s) isreceived, process 1800 proceeds YES to store the settings as defaults1890, in which the previous default settings, including previouslyconfigured default settings, if any, are replaced with the newlyconfigured settings. In an embodiment, such configurations are storedthrough the use of Extensible Markup Language (XML) files. However, anytype of storage capabilities understood by those of skill in the art maybe used without departing from the spirit and scope of the presentdisclosure. Process 1800 then terminates at END operation 1891, in whichthe configure task settings UI is closed, according to embodiments.

Returning to query 1889, if an indication to store the configurations isnot received, process 1800 proceeds NO to receive an indication to resetthe settings query 1892, in which it is determined whether a selectionto reset the settings to the factory default settings is received 1892.If a selection to reset the settings is received, process 1800 proceedsYES to reset the settings to the default values 1893. Process 1800 thencontinues to query 1889. If no indication to reset at query 1892 isreceived, process 1800 proceeds NO to query 1894 to determine whether anindication to cancel the configuration is received. If an indication tocancel is received, process 1800 proceeds YES to exit the configureconfirmation table view 1895, and process 1800 then terminates at ENDoperation 1896. If no indication to cancel is received at query 1894,process 1800 proceeds NO to receive another indication 1897, such as anindication to move to another screen, for example, through the selectionof a button, control, or other icon, according to an embodiment. Thesystem responds 1898 to the selection of the other indication 1897, asapplicable, e.g., moving to another screen in an embodiment selectingthe next screen, for example, and process 1800 terminates at ENDoperation 1896.

While FIGS. 18A, 18B, 18C, and 18D depict example process 1800 forconfiguring a pre-defined task, FIGS. 19A, 19B, 19C, and 19D illustrateexample operational steps 1900 for configuring a custom or user-definedtask, in accordance with embodiments of the present disclosure. Startoperation 1902 is initiated, and process 1900 proceeds to operation 1904for receiving a selection to configure. Configuration selection options,including GUI elements to select to configure system settings, displaysettings, task settings, etc., are provided 1906. A selection toconfigure the default settings for tasks is then received 1908. Thetypes of tasks for selection are then provided 1910, and a selection ofa custom task, e.g., Custom Task 1, is received 1912. The defaultsettings for the selected custom task are then retrieved 1914 fromstorage, for example. The default settings are then provided in aconfigure confirmation view 1916, in accordance with an embodiment. Infurther embodiments, the configure confirmation view comprises a tableformat for listing the settings. Next, query 1918 determines whether aselection is received to add a step to the custom task. In anembodiment, a custom task includes a single step by default. If aselection to add a step is received, process 1900 proceeds YES to addthe step and retrieve the default settings for the added step 1920.Process 1900 then continues to operation 1916 for providing the defaultsettings in the configure confirmation table view, according toembodiments. If no step is desired to be added at query 1918, process1900 proceeds NO through off-page reference A 1922 to query 1924 of FIG.19B. While query 1918 determines whether a step is to be added, otherembodiments provide for a user or operator to select to add a step at alater time, for example, in another UI, e.g., in the diagram view orwindow for configuring, etc. Embodiments provide for numerous types ofwindows to provide the functionality to add a step(s). Query 1918 isoffered as an example for determining whether to add a step in process1900. As noted, other embodiments provide for a step(s) to be addedbefore or after query 1918, etc.

As process 1900 continues through off-page reference A 1922 to query1924 of FIG. 19B, it is determined whether an indication is received toconfigure the settings for a step or process associated with theselected task and displayed in the configure confirmation UI. If aselection to configure the settings for a step is not received, process1900 proceeds NO to query 1926, in which it is determined whether aselection to cancel the configuration is received. If an indication tocancel is received, process 1900 proceeds YES to close the configurationwindow 1928 and exit the configuration screen. Process 1900 thenterminates at END operation 1930, in which a home screen of the cellexpansion system may appear, according to embodiments. If an indicationto cancel is not received at query 1926, process 1900 proceeds NO toreceive another indication 1932, such as to switch to another screenthrough a selection of a next screen button, control, or icon, forexample. The indication received is responded to 1934, and process 1900then terminates at END operation 1930.

Returning to query 1924, if an indication to configure settings for astep is received, process 1900 proceeds YES to determine the stepselected 1936, and the setting(s) associated with the selected step areretrieved 1938. The retrieved setting(s) are associated with GUIelement(s) 1939. For example, the system associates 1939 a setting,e.g., a first setting, with a GUI element, e.g., a first GUI element.The GUI element may be further associated with data associated with thesetting, e.g., default data, according to embodiments. For example, aGUI element may be associated with a numeric value, a media type, e.g.,Cells, Reagent, etc., depending on the associated setting type. Inembodiments, a first GUI element displayed in the diagram view shows thedefault data associated with the first GUI element, for example.

Query 1940 next determines if specific settings are available forconfiguration, e.g., a determination is made as to whether specificsettings are configurable, in which the configurable settings areidentified by the system. As discussed above, settings may be configuredonly for those settings that are available for configuration, accordingto embodiments of the present disclosure. If a setting cannot beconfigured, the button, or other GUI element, associated with thesetting is not enabled for selection, in accordance with embodiments.For example, enabling the first GUI element for selection includesshowing that the first GUI element is capable of selection by the use ofone or more visual indicia showing such selection capabilities. Inembodiments, a GUI element that is not enabled is a first color, while aGUI element that is enabled is a second color. A visual indicia changecomprising a color change is offered for purposes of illustration.Numerous types of visual indicia changes may be used to designate a GUIelement as being enabled without departing from the spirit and scope ofthe present disclosure. For example, text may be used to show whether aGUI element is enabled or not enabled, such as by labels designating“Enabled” or “Not Enabled,” for example. Further embodiments alsoinclude using any type of indicia change without departing from thespirit and scope of the present disclosure, in which such indiciachanges are not limited to visual indicia changes.

Returning to query 1940, in response to determining that all settingsassociated with the selected step are configurable, process 1900proceeds “All” to enable for selection all GUI element(s) associatedwith the setting(s) 1944. On the other hand, in response to determiningthat only specific settings are available for configuration, process1900 branches “Specific” at query 1940 to enable specific GUI elementsfor selection 1942. A diagram view or window showing the enabled and/ornon-enabled settings is then provided, in which such providing includes:rendering the GUI element(s) 1945 and displaying the diagram view orwindow with the enabled and/or non-enabled GUI element(s) 1946. Process1900 then proceeds through off-page reference B 1948 to operation 1950of FIG. 19C.

At operation 1950 of FIG. 19C, an indication to configure a selectedsetting is received, such as by receiving a selection of a GUI elementassociated with the selected setting. Information related to theselected setting is then retrieved 1952, including information such aswhether the setting is associated with a numeric value, for example.Query 1954 determines whether the setting is associated with entry of anumeric value. If entry of a numeric value is associated with thesetting, process 1900 proceeds YES to provide data entry pad or window1956 for receiving an entry of data 1958. In embodiments, it may bedetermined whether the numeric value entered is within the availablesetting options 1960, for example. If the entry is not within theacceptable range, process 1900 proceeds to operation 1958 to receiveanother data entry. If the entry is within the available range 1960,process 1900 proceeds YES to update the setting 1962 according to thereceived value. In an embodiment, query 1960 is optional, and process1900 proceeds to update the setting 1962 according to the receivedvalue.

Further, in updating the selected setting 1962, or after such updating,for example, embodiments may provide for a second setting to beautomatically calculated based on the value received for the firstsetting. In an embodiment, such calculations occur automatically. Inanother embodiment, such calculations are optional. As an example, atask may include a pump rate, such as the IC Circulation Rate, that thesystem automatically calculates based on another pump rate for the task,such as the IC Inlet Rate. A user or operator may override anautomatically calculated pump rate, according to an embodiment of thepresent disclosure. In another embodiment, a user or operator may not bepermitted to override the automatically calculated pump rate. Inembodiments, setting options indicate whether an automaticallycalculated value may be overridden. Process 1900 then proceeds throughoff-page reference C 1976 to query 1977 of FIG. 19D.

Returning to query 1954, if it is determined that the selected settingis not associated with a numeric value, process 1900 proceeds NO toquery 1964 to determine if a menu, list, or window, for example, ofselection options is associated with the selected setting. If a window,list, or menu, for example, of selection options is associated with theselected setting, process 1900 proceeds YES to retrieve the applicableoptions 1966. In an embodiment, such selection options are predeterminedor pre-defined. The menu, list, or window of selection options is thenprovided 1968, and a selection of an option is received 1970. Forexample, “Wash” is selected for the IC Inlet setting, according to anembodiment of the present disclosure. In another embodiment, a numericvalue is selected, for example. The selected setting is then updated1962. In an embodiment, any automatically calculated settings (based onany received data for the selected setting, for example) are alsoupdated at update setting operation 1962. In another embodiment, anyautomatically calculated settings are updated after update settingoperation 1962. Process 1900 next proceeds through off-page reference C1976 to query 1977 of FIG. 18D.

Returning to query 1964, where a menu, list, or window, for example, ofselection options is not associated with the selected setting, process1900 proceeds to operation 1972 for providing another input/selectioncapability, such as a field, radio button, control, checkbox, etc.,according to embodiments of the present disclosure. Input or a selectionis received at operation 1974, and the selected setting is updated 1962.In an embodiment, any automatically calculated settings (based on anyreceived data for the selected setting, for example) are also updated atupdate setting operation 1962. In another embodiment, any automaticallycalculated settings are updated after update setting operation 1962.Process 1900 then proceeds through off-page reference C 1976 to query1977 of FIG. 18D.

At query 1977 of FIG. 19D, it is determined whether a confirmation ofthe configured setting(s) is received. If no confirmation is received,process 1900 proceeds NO to determine whether a selection to include oromit a step is received 1978. If such a selection is received, theappropriate application of the request occurs 1979, and process 1900then proceeds to query 1977. If no steps are included or omitted atquery 1978, process 1900 proceeds NO to query 1980 for determiningwhether a selection to configure other settings is received. If othersettings are desired to be configured, process 1900 proceeds YES tooff-page reference D 1981, in which process 1900 continues to operation1950 of FIG. 19C. If no selection is received to configure anothersetting(s), process 1900 proceeds NO to receive an indication toconfigure another step(s) of the selected task 1982. Process 1900 thenproceeds through off-page reference E 1983 to operation 1936 of FIG.19B. Returning to query 1977, if a confirmation of the configuration isreceived, process 1900 proceeds YES to provide an updated configureconfirmation view 1984, in which the settings, including any configuredsettings, are provided in the updated view 1984. In embodiments, theupdated configure confirmation view comprises a table format. Query 1985next determines whether an indication is received in the updatedconfigure confirmation view of the settings to configure any otherstep(s). If a selection for configuring other step(s) is received,process 1900 proceeds YES through off-page reference E 1983 to operation1936 of FIG. 19B. If no other configuration of steps is desired, process1900 proceeds NO to query 1986 to determine whether the configurationsare to be stored. If an indication to save the configuration(s) isreceived, process 1900 proceeds YES to store the settings as defaults1987, in which the previous default settings, including previouslyconfigured default settings, if any, are replaced with the newlyconfigured settings. Process 1900 then terminates at END operation 1988,in which the configure task settings UI is closed, according toembodiments.

Returning to query 1986, if an indication to store the configurations isnot received, process 1900 proceeds NO to receive an indication to resetthe settings query 1989, in which it is determined whether a selectionto reset the settings to the factory default settings is received 1989.If a selection to reset the settings is received, process 1900 proceedsYES to reset the settings to the default values 1990. Process 1900 thencontinues to query 1986. If no indication to reset is received, process1900 proceeds NO to query 1991 to determine whether an indication tocancel the configuration is received. If an indication to cancel isreceived, process 1900 proceeds YES to exit the configure confirmationview 1992, and process 1900 then terminates at END operation 1993. If noindication to cancel is received at query 1991, process 1900 proceeds NOto receive another indication 1994, such as an indication to move toanother screen through the use of a button, control, or icon, accordingto an embodiment. The system responds 1995 to the selection of the otherindication 1994, as applicable, e.g., moving to another screen in anembodiment selecting the next screen, for example, and process 1900terminates at END operation 1993.

While FIGS. 19A, 19B, 19C, and 19D depict example steps for receiving,such as by the system, for example, configuration settings, FIGS. 20Aand 20B illustrate example operational steps 2000 for modifying, fromthe perspective of a user or operator, device, program, etc., forexample, a protocol or task for use with the system, in accordance withembodiments of the present disclosure. Start operation 2002 isinitiated, and process 2000 proceeds to select a task or protocol 2004for use with the cell expansion system. The types of tasks or protocolsare received 2006, including pre-defined and/or custom task types, inaccordance with embodiments disclosed herein. A task type is thenselected 2008, and the default settings for the selected task arereceived 2010. In an embodiment, the default settings for the selectedtask are displayed in a setup confirmation view 2010, in which the setupconfirmation view comprises a table view in embodiments. A determination2012 is made as to whether to modify a process, or step, for theselected task or protocol. If it is not desired to modify a setting fora process or step, process 2000 proceeds NO to query 2014 to determineif the selected task or protocol should be executed. If it is desired torun the task or protocol, process 2000 proceeds YES to select to executethe task 2016. In an embodiment, an indication to execute the taskcomprises selecting a “Start” button or other UI element indicating torun the task. The task or protocol is then executed, and process 2000terminates at END operation 2018. If it is not desired to execute thetask, another indication is selected 2020, such as an indication tocancel, for example, in which the current view or window is closed, anda home screen appears, according to an embodiment. Process 2000 thenterminates at END operation 2018.

Returning to query 2012, if it is desired to modify a setting(s) for aprocess, or step, process 2000 proceeds YES to select the step to modify2022. In an embodiment, selecting the step to modify comprises selectinga “Modify” button or other type of GUI element designating modificationfunctionalities for a particular step in the setup view, in which thesetup view, in embodiments, comprises a table format. Process 2000 thenproceeds to receive a diagram view or window with those settings capableof being modified shown as enabled GUID elements in the diagram view orwindow 2024. A selection of an enabled GUI element associated with thedesired setting to modify is made 2026, and process 2000 then proceedsthrough off-page reference A 2028 to query 2030 of FIG. 20B.

At query 2030 of FIG. 20B, it is determined if a data entry pad orwindow, a menu, list, or window, for example, of selection options, oranother input/selection capability is received. If a data entry pad isreceived, process 2000 proceeds to operation 2034, in which a numericvalue is entered. In an embodiment, the numeric value entered is withinsetting options for the associated setting. In another embodiment, thenumeric value entered is not within the setting options for theassociated setting, and another numeric value or other input data isthen provided. Next, process 2000 proceeds to query 2036 to determine ifthe settings can be confirmed as those that are desired.

Returning to query 2030, if a menu, list, or window, for example, ofselection options is received, process 2000 proceeds to select an optionfrom the menu or window 2040. Next, process 2000 proceeds to query 2036to determine if the settings can be confirmed as those that are desired.If, at query 2030, another input/selection capability is received,including means to provide data or make a selection through means otherthan a data entry pad/window or a menu/window of options, process 2000proceeds to select an option or provide input 2044. Next, process 2000proceeds to query 2036 to determine if the settings can be confirmed asthose that are desired.

If the settings are not confirmed, process 2000 proceeds NO, in whichanother setting(s) is selected for modification 2046, and process 2000then continues to query 2030. If, at query 2036, the modified settingsare confirmed, process 2000 proceeds YES to receive an updated setupconfirmation view including the modified setting(s) 2048. In anembodiment, the updated setup confirmation view comprises data for thesettings in a table format. In the setup confirmation view, a selectionmay be made to select another step(s) to modify 2050. If such aselection is made, process 2000 proceeds YES through off-page referenceB 2052 to operation 2022 of FIG. 20A. If it is not desired to modify anyother step(s), process 2000 proceeds to query 2054 to determine whetherto select to execute the task. If it is desired to execute the task2054, the selection to run the protocol is made. The system thenperforms the selected protocol, and process 2000 terminates at ENDoperation 2056. If a selection to execute the task is not made at query2054, process 2000 proceeds NO to query 2058 to select to reset themodified setting(s) to the factory default settings. If it is desired toreset the setting(s), process 2000 proceeds YES to select to reset thesettings to the default values 2060. If it is not desired to reset thesettings, process 2000 proceeds NO to query 2062 to determine whether tocancel the modifying of any setting(s). If it is desired to cancel andexit the current screen, process 2000 proceeds YES to terminate process2000 at END operation 2064, in which the current screen is closed,according to an embodiment. If it is not desired to cancel, process 2000proceeds NO to enter another indication 2066, in which entering anotherindication comprises, for example, selecting a button, control, or iconto switch between the current page and another page. Other types ofindications may be made in accordance with other embodiments. Process2000 then terminates at END operation 2064.

While FIGS. 20A and 20B provide example steps for selecting to modify asetting of a task or protocol, from a user or operator perspective, forexample, FIG. 21 depicts example operational steps 2100 for creating acustom or user-defined task from the perspective of a user or operator,according to embodiments of the present disclosure. Start operation 2101is initiated, and process 2100 proceeds to select a task 2102, in whicha “task” button or other GUI element is selected, for example. Protocolor task types are then received 2104, in which such task types include apre-defined task type and a custom task type, according to embodiments.A custom task is selected 2106, and a list of available custom tasks,e.g., Custom Task 1, Custom Task 2, Custom Task 3, Custom Task 4, CustomTask 5, etc., is received 2108. A specific custom task, e.g., CustomTask 1, is then selected 2110, and default settings for the selectedcustom task are received 2112. In an embodiment, such default settingsinclude the factory default settings for the selected custom task. Inanother embodiment, the default settings include settings previouslyconfigured and stored for the selected custom task.

Next, query 2114 determines whether it is desired to add a step(s) tothe custom task. For example, the following step(s) may be selected:Wash Out Lines, Wash Out Lines Through Membrane, Wash Rapidly, HarvestCells, Add Bolus, and Custom, according to embodiments. If a selectionis made to add a step(s), process 2100 proceeds YES to receive defaultsettings for the selected additional step(s) 2122. Process 2100 thencontinues to query 2114. If no other steps are desired to be added,process 2100 proceeds NO to determine whether it is desired to select toconfigure a step(s) 2116. If it is desired to configure a step(s),process 2100 proceeds YES to configure operation 2118, in which adesired configuration is provided for the selected step(s). A selectionis made to save the configuration(s) 2119. The system stores theconfiguration, and process 2100 then terminates at END operation 2120.Returning to query 2116, if it is not desired to configure a step(s),process 2100 proceeds NO to select to execute the task query 2124. If itis desired to execute the task, process 2100 proceeds to operation 2126,in which information regarding the performance of the task is receivedafter task execution. Process 2100 then terminates at END operation2120. However, if it is not desired to execute the task at query 2124,process 2100 proceeds to query 2128 to determine whether to modify asetting(s) of the custom task. If it is desired to modify a setting(s),process 2100 proceeds YES to provide the desired modification 2130.Following modify operation 2130, process 2100 proceeds to confirm themodification(s) 2131. In embodiments, process 2100 then proceeds toquery 2132 to determine if another action, such as to cancel, move toanother screen through selection of a button, control, or icon, forexample, is selected. If no other action is selected, process 2100proceeds to query 2124 to determine whether to execute the task.Returning to query 2132, if another action is selected, process 2100proceeds YES, in which the system responds to the selected action, andprocess 2100 then terminates at END operation 2120. Further, returningto query 2128, if it is not desired to modify a setting, process 2100proceeds NO to determine whether to select another action 2132. If noother action is selected, process 2100 proceeds to query 2124 todetermine whether to execute the task. On the other hand, if anotheraction is selected at query 2132, process 2100 proceeds YES, in whichthe system responds to the selected action, and process 2100 thenterminates at END operation 2120.

While FIG. 21 provides for creating a custom task, from the perspectiveof a user or operator, for example, FIGS. 22A, 22B, and 22C illustrateexample operational steps 2200 for configuring a task, from theperspective of a user or operator, for example, in accordance withembodiments of the present disclosure. Start operation 2202 isinitiated, and process 2200 then proceeds to select to configureoperation 2204, in which a selection of a “Configuration” GUI element,e.g., button, may be made according to an embodiment. In response to theconfiguration selection, configuration options are received 2206, inwhich such configuration options include system settings, displaysettings, and/or protocol or task default settings, for example. Aselection is then made to configure the default settings for a task2208, and the task type options are received 2210. A type of task isthen selected 2212, and default settings for the selected task type arereceived 2214. In an embodiment, such default settings are received in aconfigure confirmation view, in which the configure confirmation viewincludes settings and data for the settings. According to an embodiment,the settings and associated data in the configure confirmation view aredisplayed in a table format. Next, it is determined whether the selectedtask is a custom or user-defined task at query 2216. If a custom taskselection is made at operation 2212, process 2200 proceeds YES to query2218 to determine if a step is desired to be added. If adding a step isdesired, process 2200 proceeds YES to select a step to add 2220. Defaultsettings for the added step are then received 2222. Process 2200 thecontinues through off-page reference A 2224 to query 2226 of FIG. 22B.If it is not desired to add a step to the custom task, process 2200proceeds NO to off-page reference A 2224, and process 2200 then proceedsto query 2226. Returning to query 2216, if a pre-defined task isselected instead of a custom task at operation 2212, process 2200proceeds NO through off-page reference A 2224 to query 2226.

Next, at query 2226, it is determined whether to configure a setting(s)of a step. If it is desired to configure a setting(s) of a step, process2200 proceeds YES to select a step to configure 2238. The settingsassociated with the selected step are then received 2240. In anembodiment, the setting(s) associated with a step(s) are received in adiagram view of the cell expansion system. A selection to configure afirst setting is made 2242. Depending on the type of setting selected tobe configured, a data entry pad or window; menu, list, or window, forexample, of selection options; or other input/selection capability isreceived 2244. In an embodiment, selection options in a menu, list, orwindow, for example, are predetermined or pre-defined. Where a dataentry pad or window is received 2246, process 2200 proceeds to enter anumeric value 2248. In an embodiment, the entered numeric value iswithin the setting options. In another embodiment, the entered numericvalue is not within the setting options, e.g., range of acceptablevalues, and another numeric value is entered 2248. In yet anotherembodiment, it is optional to determine whether the entered numericvalue is within the setting options. Process 2200 then proceeds throughoff-page reference B 2250 to query 2258 of FIG. 22C. Returning to query2244, where a menu, list, or window of selection options is received,process 2200 proceeds to select an option from the selection choices2252. Process 2200 then proceeds through off-page reference B 2250 toquery 2258 of FIG. 22C. In another embodiment, if another input orselection capability is received, process 2200 proceeds to select theoption or provide input 2256, and process 2200 then proceeds throughoff-page reference B 2250 to query 2258 of FIG. 22C.

Turning to FIG. 22C, a selection may be made to confirm the configuredsetting(s) 2258. If no confirmation is made, process 2200 proceeds NO toselect to configure other setting(s) 2260. Process 2200 then proceedsthrough off-page reference C 2262 to operation 2242 of FIG. 22B. If thesettings are confirmed at query 2258, process 2200 proceeds YES toreceive an updated setup confirmation view 2264. In an embodiment, theupdated setup confirmation view 2264 includes the step(s) or process(es)and setting(s) associated with the protocol or task in a table format.Within the setup confirmation screen 2264, if a selection is made toconfigure another step(s) 2266, process 2200 then proceeds YES throughoff-page reference D 2268 to operation 2238 of FIG. 22B. If no othersteps are selected to configure, process 2200 proceeds NO to query 2270,in which it is determined whether to select to save theconfiguration(s). If it is indicated to save the configuration(s),process 2200 proceeds YES to END operation 2272, and process 2200terminates. In an embodiment, process 2200 terminates by storing, by thesystem, the configuration(s) made, and closing the current screen. If aselection to save is not made at query 2270, process 2200 proceeds NO toquery 2274 to determine whether to select to reset a configuredsetting(s) to the factory default setting(s). If a selection is made toreset the setting(s), process 2200 proceeds YES to receive resetsettings 2276. Process 2200 then proceeds to query 2270 to determinewhether to save the setting(s). If, at query 2274, a selection is notmade to reset the settings, process 2200 proceeds NO to query 2278 todetermine if a selection is made to cancel the configuration. If aselection is made to cancel, process 2200 proceeds YES to END operation2280, in which process 2200 is terminated, such as by closing thecurrent screen, according to an embodiment. If a selection is not madeto cancel at query 2278, process 2200 proceeds NO to enter anotherindication 2282, such as selecting a button, control, or icon to move toanother page, for example. In embodiments, the system responds to theselected action, and process 2200 then terminates at END operation 2280.

With respect to the processes illustrated in FIGS. 14A, 14B, 14C, 14D,15A, 15B, 16, 17, 18A, 18B, 18C, 18D, 19A, 19B, 19C, 19D, 20A, 20B, 21,22A, 22B, and 22C, the operational steps depicted are offered forpurposes of illustration and may be rearranged, combined into othersteps, used in parallel with other steps, etc., according to embodimentsof the present disclosure. Where queries are depicted as operationalsteps, such queries may be determined by event-based interactions,polling, and/or other means or processes, according to embodiments.Further, fewer or additional steps may be used in embodiments withoutdeparting from the spirit and scope of the present disclosure.

Turning to FIG. 23 , an example data structure 2300 having attributes,fields, and/or portions storing data is provided in accordance withembodiments disclosed herein. The data structure may be part of anystorage system. The data structure includes a task or protocol, and, inembodiments, the task or protocol data further comprises identifyingdata 2302. One or more tasks or protocols may be included, as shown byellipsis 2320 and additional task identifying data 2322. Embodimentsfurther provide for each protocol or task to have a step or processassociated with the protocol or task, in which embodiments provide forthe step or process to further comprise identifying data 2304. Further,each protocol or task 2302 and/or 2322, for example, may have one ormore additional steps or processes associated therewith, as shown bystep identifying data 2314, ellipsis 2316, and additional step 2318 forprotocol or task 2302, and step identifying data 2323, 2324, andellipsis 2326 for protocol or task 2322.

In embodiments, each process or step may comprise data including defaultsettings 2305, 2306, 2307, 2309, 2311, 2313, and 2315. In an embodiment,the default settings 2306 comprise data associated with particularsettings, including, for example, the IC Inlet, IC Inlet Rate, etc. Inan embodiment, default settings 2306 comprise the factory defaultsettings stored by the system. In another embodiment, the defaultsettings comprise previously configured and saved settings, in whichsuch previously configured settings replaced the factory defaultsettings as the new default settings. In yet another embodiment, evenwhere the default settings are configured, the factory default settingsare also saved with data 2306, or, in another embodiment, as other datain data structure 2300, as an embodiment provides for resettingconfigured settings to the factory default settings. Where suchresetting of the settings is desired, data for the factory defaultsettings are retrieved.

In embodiments, data structure 2300 further comprises data for settingoptions 2308, 2327, 2329, 2331, 2333, 2335, and 2337, in which thesetting options comprise ranges, for example, of possible data that maybe provided for one or more settings. For example, embodiments involvinga custom or user-defined task include setting options for the IC InletRate of: 0 to 500 mL/min. Other data, including additional or fewerdata, associated with data structure 2300 may be included as shown byellipses 2310, 2339, and 2343 and Other data 2312, 2341, and 2345,according to embodiments. For example, other data associated with aprotocol or task may include, according to an embodiment, dataindicating the type of GUI element used to represent a setting in adiagram view or window of the cell expansion system, for example.

The data types depicted in the example data structure 2300 of FIG. 23are offered for purposes of illustration. The order of the data typesmay be rearranged, according to embodiments. Further, fewer oradditional data attributes, fields, and/or portions may be used inembodiments without departing from the spirit and scope of the presentdisclosure. Further, numerous types of names referring to the dataattributes, fields, and/or portions may be used without departing fromthe spirit and scope of the present disclosure.

Finally, FIG. 24 illustrates example components of a cell expansionsystem 702 upon which embodiments of the present disclosure may beimplemented. The cell expansion system 702 may include a user interface2410, a processing system 2402, and/or storage 2408. The user interface2410 may include output device(s) 2412, and/or input device(s) 2414 asunderstood by a person of skill in the art. Output device(s) 2412 mayinclude one or more touch screens, in which the touch screen maycomprise a display area for providing one or more application windows.The touch screen may also be an input device 2414 that can receiveand/or capture physical touch events from a user or operator, forexample. The touch screen may comprise a liquid crystal display (LCD)having a capacitance structure that allows the processing system 2402 todeduce the location(s) of touch event(s), as understood by those ofskill in the art. The processing system 2402 may then map the locationof touch events to UI elements rendered in predetermined locations of anapplication window. The touch screen may also receive touch eventsthrough one or more other electronic structures, according toembodiments. Other output devices 2412 may include a printer, speaker,etc. Other input devices 2414 may include a keyboard, other touch inputdevices, mouse, voice input device, etc., as understood by a person ofskill in the art.

Processing system 2402 may include a processing unit 2404 and/or amemory 2406, according to embodiments of the present disclosure. Theprocessing unit 2404 may be a general purpose processor operable toexecute instructions stored in memory 2406. Processing unit 2404 mayinclude a single processor or multiple processors, according toembodiments. Further, in embodiments, each processor may be a multi-coreprocessor having one or more cores to read and execute separateinstructions. The processors may include general purpose processors,application specific integrated circuits (ASICs), field programmablegate arrays (FPGAs), other integrated circuits, etc., as understood by aperson of skill in the art.

The memory 2406 may include any short-term or long-term storage for dataand/or processor executable instructions, according to embodiments. Thememory 2406 may include, for example, Random Access Memory (RAM),Read-Only Memory (ROM), or Electrically Erasable Programmable Read-OnlyMemory (EEPROM), as understood by a person of skill in the art. Otherstorage media may include, for example, CD-ROM, tape, digital versatiledisks (DVD) or other optical storage, tape, magnetic disk storage,magnetic tape, other magnetic storage devices, etc., as understood by aperson of skill in the art.

Storage 2408 may be any long-term data storage device or component.Storage 2408 may include one or more of the systems described inconjunction with the memory 2406, according to embodiments. The storage2408 may be permanent or removable. In embodiments, storage 2408 storesdata generated or provided by the processing system 2402.

It will be apparent to those skilled in the art that variousmodifications can be made to the apparatus, systems, and methodsdescribed herein. Thus, it should be understood that the embodiments arenot limited to the subject matter discussed in the Specification.Rather, the present disclosure is intended to cover modifications,variations, and/or equivalents. The acts, features, structures, and/ormedia are disclosed as illustrative embodiments for implementation ofthe claims. The invention is defined by the appended claims.

What is claimed is:
 1. A non-transitory processor-readable storagemedium storing executable instructions which, when executed by aprocessor, perform a method of customizing a protocol for use with acell expansion system, the method comprising: receiving a firstselection, in a user interface associated with the cell expansionsystem, to customize a first protocol for expanding a plurality of cellsin a bioreactor of the cell expansion system, wherein the user interfaceis operable to display data and receive an input; in response toreceiving the first selection, providing, through the user interface, adiagram view of the cell expansion system for customizing the firstprotocol, comprising: providing a first setting for the first protocolas a first graphical user interface (GUI) element for selection;receiving, through the user interface, a second selection of the firstGUI element; receiving, through the user interface, a first value forthe first GUI element; receiving a third selection to execute the firstprotocol; and executing the first protocol using the first value for thefirst setting to expand the plurality of the cells.
 2. Thenon-transitory processor-readable storage medium as defined in claim 1,the method further comprising: providing, through the user interface,one or more types of processes to add; receiving, through the userinterface, a fourth selection of a first process; and in response toreceiving the fourth selection, associating the diagram view with thefirst process.
 3. The non-transitory processor-readable storage mediumas defined in claim 2, wherein the one or more types of processes to addcomprises: wash out lines, wash out lines through membrane, washrapidly, harvest cells, add bolus, and/or custom.
 4. The non-transitoryprocessor-readable storage medium as defined in claim 1, the methodfurther comprising: determining the first setting is associated with anumeric value; and in response to determining the first setting isassociated with the numeric value, providing a data entry pad in thediagram view to receive the first value.
 5. The non-transitoryprocessor-readable storage medium as defined in claim 4, the methodfurther comprising: receiving, through the data entry pad, the firstvalue for the first setting; and storing the first value for the firstsetting.
 6. The non-transitory processor-readable storage medium asdefined in claim 1, the method further comprising: determining the firstsetting is associated with a menu of selection options; and in responseto determining the first setting is associated with the menu ofselection options, providing the menu of selection options in thediagram view.
 7. The non-transitory processor-readable storage medium asdefined in claim 1, wherein the user interface comprises a touch screen.8. The non-transitory processor-readable storage medium as defined inclaim 7, wherein the touch screen comprises an input device that canreceive one or more touch events.
 9. The non-transitoryprocessor-readable storage medium as defined in claim 8, wherein thereceiving the first selection comprises: receiving a touch event on thetouch screen, wherein the touch screen comprises a display area;determining a location of the touch event; mapping the location of thetouch event to the first GUI element; and determining the first GUIelement is associated with the first setting.
 10. The non-transitoryprocessor-readable storage medium as defined in claim 1, wherein thefirst setting comprises: intracapillary inlet, intracapillary inletrate, intracapillary circulation rate, extracapillary inlet,extracapillary inlet rate, extracapillary circulation rate, rocker,and/or stop condition.
 11. The non-transitory processor-readable storagemedium as defined in claim 1, wherein the providing the first settingfor the first protocol as the first GUI element for selection comprises:enabling the first GUI element for selection.
 12. The non-transitoryprocessor-readable storage medium as defined in claim 11, wherein theenabling the first GUI element for selection comprises: associating afirst visual indicator with the first GUI element; and in response todetermining the first setting can be modified, associating a secondvisual indicator with the first GUI element.
 13. The non-transitoryprocessor-readable storage medium as defined in claim 1, wherein theproviding, through the user interface, the diagram view of the cellexpansion system for customizing the first protocol comprises: depictingan intracapillary space of the bioreactor in the diagram view; anddepicting an extracapillary space of the bioreactor in the diagram view.14. The non-transitory processor-readable storage medium as defined inclaim 2, the method further comprising: receiving, through the userinterface, a fifth selection of a second process.
 15. The non-transitoryprocessor-readable storage medium as defined in claim 14, the methodfurther comprising: providing, through the user interface, a seconddiagram view of the cell expansion system for customizing the firstprotocol, comprising: associating the second diagram view with thesecond process in the user interface.
 16. A method of customizing aprotocol for use with a cell expansion system, the method comprising:receiving a first selection, in a user interface associated with thecell expansion system, to customize a first protocol for expanding aplurality of cells in a bioreactor of the cell expansion system, whereinthe user interface is operable to display data and receive an input; inresponse to receiving the first selection, providing, through the userinterface, a diagram view of the cell expansion system for customizingthe first protocol, comprising: providing a first setting for the firstprotocol as a first graphical user interface (GUI) element forselection; receiving, through the user interface, a second selection ofthe first GUI element; receiving, through the user interface, a firstvalue for the first GUI element; receiving a third selection to executethe first protocol; and executing the first protocol using the firstvalue for the first setting to expand the plurality of the cells. 17.The method as defined in claim 16, further comprising: providing,through the user interface, one or more types of processes to add;receiving, through the user interface, a fourth selection of a firstprocess; and in response to receiving the fourth selection, associatingthe diagram view with the first process.
 18. The method as defined inclaim 17, wherein the one or more types of processes to add comprises:wash out lines, wash out lines through membrane, wash rapidly, harvestcells, add bolus, and/or custom.
 19. The method as defined in claim 17,further comprising: receiving, through the user interface, a fifthselection of a second process; and in response to receiving the fifthselection: providing, through the user interface, a second diagram viewof the cell expansion system for customizing the first protocol,comprising: associating the second diagram view with the second processin the user interface.
 20. The method as defined in claim 17, furthercomprising: determining the first setting is associated with a numericvalue; and in response to determining the first setting is associatedwith the numeric value, providing a data entry pad in the diagram viewto receive the first value.